A Phase 1 interventional study of vibostolimab and pembrolizumab in Neoplasms, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
This is a safety, efficacy, and pharmacokinetics (PK) study of vibostolimab (MK-7684) as monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in adults with metastatic solid tumors for which there is no available therapy that is expected to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase to estimate the recommended Phase 2 dose (RPTD) for vibostolimab monotherapy or in combination with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor activity of vibostolimab in combination with pembrolizumab plus pemetrexed and carboplatin in participants with non-small cell lung cancer (NSCLC) and vibostolimab (at two dose levels) in combination with pembrolizumab in Japanese participants with gastric cancer. Part B will evaluate the anti-tumor activity of vibostolimab at the RPTD when used as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors in a non-randomized study design. Part B will also evaluate 2 doses of vibostolimab in combination with pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized study design. Part B is expanded with Amendment 11 to include an additional arm that will compare the safety and PK of a fixed dose of pembrolizumab/vibostolimab coformulation (MK-7684A) to vibostolimab in combination with pembrolizumab administered as separate intravenous infusions. Part A is expanded with Amendment 12 to include an additional arm that will compare the safety and PK of vibostolimab plus pembrolizumab plus the investigator's choice of platinum agent (carboplatin or cisplatin), and etoposide. Part B is expanded with Amendment 12 to include evaluation of efficacy of vibostolimab plus pembrolizumab plus the investigator's choice of platinum agent (carboplatin or cisplatin), and etoposide and efficacy of pembrolizumab/vibostolimab coformulation in participants from mainland China. The primary hypotheses are that vibostolimab administered as monotherapy or in combination with pembrolizumab is safe and tolerable when administered at the RPTD and that pembrolizumab/vibostolimab coformulation is safe and tolerable when administered as a fixed dose.
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Exclusion Criteria:
During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD has been established. The RPTD will be established based on the number of dose limiting toxicities (DLTs) at each dose level. Once the RPTD is established, participants will continue receiving the RPTD of vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab has been established. The RPTD will be established based on the number of DLTs at each dose level. Once the RPTD of vibostolimab is established, participants will continue receiving the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Participants will receive the RPTD of vibostolimab monotherapy or the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Participants will receive a fixed dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m\^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a fixed dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m\^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
Biological: vibostolimab · Biological: pembrolizumab · Drug: pemetrexed · Drug: carboplatin
Japanese participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Japanese participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab · Biological: pembrolizumab
Participants will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Biological: pembrolizumab/vibostolimab coformulation
Participants will receive 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m\^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m\^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Biological: vibostolimab · Biological: pembrolizumab · Drug: carboplatin · Drug: cisplatin · Drug: etoposide
Participants from mainland China will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Biological: pembrolizumab/vibostolimab coformulation
Administered as an intravenous (IV) infusion on Day 1 of 21-day infusion Cycles 1-35
Also known as: MK-7684
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
Also known as: KEYTRUDA®, MK-3475
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
Also known as: ALIMTA®
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4
Also known as: PARAPLATIN®
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
Also known as: MK-7684A
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4
Also known as: PLATINOL-AQ®
Administered as an IV infusion on Days 1-3 of 21-day infusion Cycles 1-4
Also known as: ETOPOPHOS®
Number of Participants With Dose Limiting Toxicities (DLTs) up to 24 Months
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE4.0).
Time frame: Up to 24 Months
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Time frame: Up to 28 Months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Time frame: Up to 24 Months
Overall Response Rate (ORR) in Participants in Vibostolimab Dose Escalation Phase Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants treated with vibostolimab dose escalation are presented.
Time frame: Up to 24 Months
ORR in Participants With Programmed Death 1 (PD-1) Refractory Non-small Cell Lung Cancer (NSCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 refractory NSCLC treated with 200 or 210 mg vibostolimab in dose escalation as well as dose expansion phases are presented.
Time frame: Up to 24 Months
ORR in Participants With PD-1 Naive NSCLC Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive NSCLC treated with pembrolizumab and 200 mg vibostolimab from both the dose escalation and expansion phases are presented.
Time frame: Up to 24 Months
ORR in Participants With Extensive-stage Small Cell Lung Cancer (ES-SCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with ES-SCLC treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide were analyzed.
Time frame: Up to 24 Months
ORR in Participants With PD-1 Naive Ovarian Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with PD-1 naive ovarian cancer treated with pembrolizumab and vibostolimab dose escalation or MK-7984A were analyzed.
Time frame: Up to 24 Months
ORR in Participants With PD-1 Naive Cervical Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive cervical cancer treated with pembrolizumab and either 200 mg or 700 mg vibostolimab are presented.
Time frame: Up to 24 Months
Area Under the Curve From Time 0 to 21 Days Postdose (AUC 0-21 Days) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5, and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22.
AUC 0-21 Days of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the AUC 0-21 days of plasma vibostolimab, Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the AUC 0-21 days of plasma pembrolizumab. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Maximum Plasma Concentration (Cmax) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Cmax of plasma vibostolimab,
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Cmax of plasma pembrolizumab.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Trough Concentration (Ctrough) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Ctrough of plasma vibostolimab,
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Ctrough of plasma pembrolizumab.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Half Life (t1/2)) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine thet1/2 of plasma vibostolimab,
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the t1/2 of plasma pembrolizumab.
Time frame: Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) at the End of Cycle 1
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by CTCAE 4.0
Time frame: At the end of Cycle 1 (up to 21 days)
Rate of Progression Free Survival (PFS) Per RECIST 1.1 at 6 Months
The progression free survival (PFS) rate is the percentage of participants who achieve PFS as estimated by the Kaplan-Meier method. PFS is the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first using RECIST, version 1.1 as assessed by investigator review. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Rate of PFS was planned and therefore only reported for participants treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide. Other treatment groups were not analyzed.
Time frame: 6 months
Participants at least 18 years of age with advanced solid tumors were enrolled in this study.
| Milestone | Vibostolimab | Vibostolimab + Pembrolizumab | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|
| Started | 68 | 295 | 60 | 11 | 40 |
| Treated | 68 | 293 | 60 | 10 | 40 |
| Crossed over | 25 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 68 | 295 | 60 | 11 | 40 |
| Withdrew: Death | 58 | 239 | 38 | 10 | 33 |
| Withdrew: Lost to follow-up | 1 | 4 | 2 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Sponsor decision | 3 | 22 | 11 | 0 | 7 |
| Withdrew: Withdrawal by subject | 6 | 27 | 9 | 0 | 0 |
| Withdrew: Not treated | 0 | 2 | 0 | 1 | 0 |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants treated with vibostolimab dose escalation are presented.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Overall Response Rate (ORR) in Participants in Vibostolimab Dose Escalation Phase Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 0.0 (0.0 to 10.3) | 7.1 (1.5 to 19.5) | — | — | — | — |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 refractory NSCLC treated with 200 or 210 mg vibostolimab in dose escalation as well as dose expansion phases are presented.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| ORR in Participants With Programmed Death 1 (PD-1) Refractory Non-small Cell Lung Cancer (NSCLC) Per RECIST 1.1 | 2.4 (0.1 to 12.9) | 5.3 (0.6 to 17.7) | — | — | — | — |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive NSCLC treated with pembrolizumab and 200 mg vibostolimab from both the dose escalation and expansion phases are presented.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| ORR in Participants With PD-1 Naive NSCLC Per RECIST 1.1 | — | 24.4 (12.4 to 40.3) | — | — | — | — |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with ES-SCLC treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide were analyzed.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| ORR in Participants With Extensive-stage Small Cell Lung Cancer (ES-SCLC) Per RECIST 1.1 | — | — | — | — | — | 75.0 (58.8 to 87.3) |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with PD-1 naive ovarian cancer treated with pembrolizumab and vibostolimab dose escalation or MK-7984A were analyzed.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| ORR in Participants With PD-1 Naive Ovarian Cancer Per RECIST 1.1 | — | 9.5 (1.2 to 30.4) | — | 7.5 (1.6 to 20.4) | — | — |
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive cervical cancer treated with pembrolizumab and either 200 mg or 700 mg vibostolimab are presented.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 200 mg | — | 14.6 (5.6 to 29.2) | — | — | — | — |
| Vibostolimab 700 mg | — | 23.1 (11.1 to 39.3) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
| day*μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | 5.42 (0.209 to 141) | 8.19 (0.267 to 252) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | 12.2 (6.58 to 22.7) | 12.0 (0.0276 to 5240) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | 12.4 (3.75 to 41.0) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | 38.3 (23.2 to 63.3) | 28.5 (7.54 to 107) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | NA (NA to NA) | 48.3 (30.9 to 75.5) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | 97.7 (24.4 to 391) | 156 (78.6 to 308) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | 339 (306 to 377) | 354 (338 to 371) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | 572 (478 to 685) | 519 (475 to 568) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | 1220 (828 to 1800) | 1250 (1120 to 1400) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | 1090 (273 to 4380) | 2080 (1800 to 2410) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the AUC 0-21 days of plasma vibostolimab, Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
| day*μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| 200 mg vibostolimab Cycle 1 | 339 (306 to 377) | 354 (338 to 371) | — | 431 (398 to 466) | 317 (267 to 378) | 476 (417 to 543) |
| 200 mg vibostolimab Cycle 4 | 572 (478 to 685) | 519 (475 to 568) | — | 655 (510 to 843) | 342 (166 to 703) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
| day*μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | — | 760 (650 to 888) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | — | 749 (457 to 1230) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | — | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | — | 516 (211 to 1260) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | — | 922 (626 to 1360) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | — | 504 (321 to 792) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | — | 516 (497 to 535) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | — | 887 (838 to 938) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | — | 541 (496 to 589) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | — | 1050 (912 to 1210) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the AUC 0-21 days of plasma pembrolizumab. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
| day*μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Cycle 1 | — | 516 (497 to 535) | — | 546 (507 to 588) | 539 (473 to 615) | 641 (601 to 682) |
| Cycle 4 | — | 887 (838 to 938) | — | 946 (765 to 1170) | 974 (815 to 1160) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | 1.52 (0.173 to 13.4) | 1.67 (0.114 to 24.5) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | 7.23 (0.914 to 57.2) | 2.09 (1.01 to 4.34) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | 7.57 (0.266 to 215) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | 8.64 (6.73 to 11.1) | 4.70 (1.48 to 14.9) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | NA (NA to NA) | 6.30 (4.22 to 9.40) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | 19.5 (11.8 to 32.3) | 24.9 (18.5 to 33.5) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | 62.6 (56.4 to 69.4) | 64.4 (60.8 to 68.2) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | 82.7 (70.0 to 97.8) | 80.1 (72.9 to 87.9) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | 202 (165 to 248) | 236 (209 to 266) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | 215 (137 to 337) | 245 (217 to 276) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Cmax of plasma vibostolimab,
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| 200 mg vibostolimab Cycle 1 | 62.6 (56.4 to 69.4) | 64.4 (60.8 to 68.2) | — | 59.9 (55.0 to 65.2) | 60.1 (51.6 to 70.1) | 59.6 (51.9 to 68.4) |
| 200 mg vibostolimab Cycle 4 | 82.7 (70.0 to 97.8) | 80.1 (72.9 to 87.9) | — | 56.4 (44.2 to 72.0) | 57.8 (45.5 to 73.5) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | — | 89.3 (76.6 to 104) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | — | 86.4 (35.9 to 208) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | — | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | — | 58.4 (29.3 to 116) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | — | 95.0 (84.4 to 107) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | — | 90.5 (79.9 to 103) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | — | 76.1 (73.7 to 78.6) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | — | 93.9 (89.3 to 98.6) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | — | 81.6 (74.6 to 89.3) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | — | 103 (94.7 to 113) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Cmax of plasma pembrolizumab.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Cycle 1 | — | 76.1 (73.7 to 78.6) | — | 66.4 (60.6 to 72.8) | 71.6 (63.2 to 81.2) | 64.4 (60.6 to 68.4) |
| Cycle 4 | — | 93.9 (89.3 to 98.6) | — | 73.2 (60.4 to 88.6) | 91.1 (78.6 to 106) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | NA (NA to NA) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | NA (NA to NA) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | NA (NA to NA) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | 0.539 (0.213 to 1.36) | 0.397 (0.0719 to 2.19) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | NA (NA to NA) | 1.11 (0.698 to 1.76) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | 3.21 (0.623 to 16.5) | 1.79 (0.240 to 13.3) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | 3.82 (2.62 to 5.57) | 5.05 (4.43 to 5.76) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | 10.7 (6.73 to 17.1) | 9.66 (8.03 to 11.6) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | 10.0 (0.929 to 108) | 19.3 (15.2 to 24.6) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | 41.3 (10.1 to 169) | 40.1 (28.2 to 57.0) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Ctrough of plasma vibostolimab,
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| 200 mg vibostolimab Cycle 1 | 3.82 (2.62 to 5.57) | 5.05 (4.43 to 5.76) | — | 8.01 (7.16 to 8.97) | 2.50 (1.10 to 5.69) | 4.16 (3.16 to 5.48) |
| 200 mg vibostolimab Cycle 4 | 10.7 (6.73 to 17.1) | 9.66 (8.03 to 11.6) | — | 15.5 (11.7 to 20.6) | 9.01 (4.24 to 19.1) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | — | 19.8 (17.5 to 22.4) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | — | 20.6 (12.4 to 34.1) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | — | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | — | 10.4 (3.27 to 33.0) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | — | 28.0 (17.6 to 44.5) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | — | 12.3 (7.10 to 21.4) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | — | 12.1 (11.4 to 12.9) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | — | 23.3 (21.4 to 25.3) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | — | 11.1 (9.31 to 13.3) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | — | 25.7 (18.9 to 35.1) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Ctrough of plasma pembrolizumab.
| μg/mL | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Cycle 1 | — | 12.1 (11.4 to 12.9) | — | 13.2 (12.1 to 14.3) | 12.5 (8.98 to 17.3) | 10.9 (10.1 to 11.8) |
| Cycle 4 | — | 23.3 (21.4 to 25.3) | — | 24.7 (19.4 to 31.3) | 31.0 (23.3 to 41.1) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| Days | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | 3.82 (0.752 to 19.4) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | 4.04 (1.46 to 11.2) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | 3.54 (1.44 to 8.52) | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | 7.19 (4.53 to 11.4) | 7.11 (4.10 to 12.3) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | NA (NA to NA) | 11.0 (7.21 to 16.7) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | 5.45 (1.05 to 28.3) | 6.55 (2.68 to 16.0) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | 7.58 (6.35 to 9.05) | 7.38 (6.92 to 7.87) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | 11.6 (8.31 to 16.1) | 10.5 (9.71 to 11.5) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | 6.04 (3.35 to 10.9) | 8.42 (7.44 to 9.53) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | 8.39 (2.26 to 31.1) | 10.7 (9.16 to 12.6) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine thet1/2 of plasma vibostolimab,
| Days | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| 200 mg vibostolimab Cycle 1 | — | 7.38 (6.92 to 7.87) | — | 9.09 (8.33 to 9.91) | 5.38 (3.31 to 8.73) | NA (NA to NA) |
| 200 mg vibostolimab Cycle 4 | — | 10.5 (9.71 to 11.5) | — | NA (NA to NA) | 10.5 (6.68 to 16.6) | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
| Days | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Vibostolimab 2.10 mg Cycle 1 | — | 19.6 (12.0 to 31.9) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 1 | — | 20.1 (14.6 to 27.7) | — | — | — | — |
| Vibostolimab 7.00 mg Cycle 4 | — | NA (NA to NA) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 1 | — | 8.84 (6.29 to 12.4) | — | — | — | — |
| Vibostolimab 21.0 mg Cycle 4 | — | 18.6 (13.0 to 26.8) | — | — | — | — |
| Vibostolimab 70.0 mg Cycle 1 | — | 13.1 (10.3 to 16.6) | — | — | — | — |
| Vibostolimab 200 mg Cycle 1 | — | 11.2 (10.6 to 11.8) | — | — | — | — |
| Vibostolimab 200 mg Cycle 4 | — | 14.3 (13.2 to 15.5) | — | — | — | — |
| Vibostolimab 700 mg Cycle 1 | — | 11.0 (9.95 to 12.2) | — | — | — | — |
| Vibostolimab 700 mg Cycle 4 | — | 16.1 (13.6 to 19.1) | — | — | — | — |
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the t1/2 of plasma pembrolizumab.
| Days | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Cycle 1 | — | 11.2 (10.6 to 11.8) | — | 12.4 (11.1 to 13.8) | 16.6 (12.6 to 21.9) | NA (NA to NA) |
| Cycle 4 | — | 14.3 (13.2 to 15.5) | — | NA (NA to NA) | 17.7 (14.8 to 21.3) | — |
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by CTCAE 4.0
| Participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) at the End of Cycle 1 | 0 | 0 | 0 | 0 | 1 | 0 |
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE4.0).
| Participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) up to 24 Months | 0 | 0 | 0 | 0 | 1 | 0 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | 67 | 284 | 24 | 60 | 10 | 40 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to an AE | 2 | 30 | 1 | 4 | 1 | 3 |
The progression free survival (PFS) rate is the percentage of participants who achieve PFS as estimated by the Kaplan-Meier method. PFS is the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first using RECIST, version 1.1 as assessed by investigator review. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Rate of PFS was planned and therefore only reported for participants treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide. Other treatment groups were not analyzed.
| Percentage of participants | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide |
|---|---|---|---|---|---|---|
| Rate of Progression Free Survival (PFS) Per RECIST 1.1 at 6 Months | — | — | — | — | — | 35.0 (20.8 to 49.6) |
Collected over All-cause mortality (ACM): from allocation up to a maximum of 28 months. Adverse events (AEs): from start of treatment up to a maximum of 28 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vibostolimab | 60/68 (88.2%) | 18/68 (26.5%) | 64/68 (94.1%) |
| Vibostolimab + Pembrolizumab | 243/295 (82.4%) | 99/293 (33.8%) | 274/293 (93.5%) |
| Vibostolimab + Pembrolizumab After Crossover | 22/25 (88%) | 7/25 (28%) | 23/25 (92%) |
| Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | 39/60 (65%) | 26/60 (43.3%) | 60/60 (100%) |
| Part B: Vibostolimab + Pembrolizumab + Pemetrexed + Carboplatin | 11/11 (100%) | 5/10 (50%) | 10/10 (100%) |
| Part B: Vibostolimab + Pembrolizumab + Carboplatin or Cisplatin + Etoposide | 33/40 (82.5%) | 13/40 (32.5%) | 40/40 (100%) |
| Event | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Part B: Vibostolimab + Pembrolizumab + Pemetrexed + Carboplatin | Part B: Vibostolimab + Pembrolizumab + Carboplatin or Cisplatin + Etoposide |
|---|---|---|---|---|---|---|
| ColitisGastrointestinal disorders | 1/68 | 4/293 | 0/25 | 0/60 | 1/10 | 1/40 |
| PyrexiaGeneral disorders | 0/68 | 4/293 | 1/25 | 0/60 | 1/10 | 1/40 |
| HepatitisHepatobiliary disorders | 0/68 | 0/293 | 0/25 | 1/60 | 1/10 | 0/40 |
| Herpes zosterInfections and infestations | 0/68 | 0/293 | 0/25 | 0/60 | 1/10 | 0/40 |
| PneumoniaInfections and infestations | 4/68 | 10/293 | 0/25 | 0/60 | 1/10 | 3/40 |
| Respiratory syncytial virus infectionInfections and infestations | 0/68 | 0/293 | 0/25 | 0/60 | 1/10 | 0/40 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/68 | 3/293 | 0/25 | 2/60 | 1/10 | 0/40 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/68 | 5/293 | 1/25 | 1/60 | 1/10 | 1/40 |
| Deep vein thrombosisVascular disorders | 0/68 | 1/293 | 0/25 | 0/60 | 1/10 | 0/40 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/68 | 0/293 | 0/25 | 1/60 | 0/10 | 2/40 |
| Event | Vibostolimab | Vibostolimab + Pembrolizumab | Vibostolimab + Pembrolizumab After Crossover | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Part B: Vibostolimab + Pembrolizumab + Pemetrexed + Carboplatin | Part B: Vibostolimab + Pembrolizumab + Carboplatin or Cisplatin + Etoposide |
|---|---|---|---|---|---|---|
| Neutrophil count decreasedInvestigations | 1/68 | 7/293 | 1/25 | 6/60 | 0/10 | 22/40 |
| FatigueGeneral disorders | 21/68 | 79/293 | 7/25 | 21/60 | 5/10 | 8/40 |
| AnaemiaBlood and lymphatic system disorders | 17/68 | 65/293 | 4/25 | 20/60 | 4/10 | 11/40 |
| DehydrationMetabolism and nutrition disorders | 2/68 | 10/293 | 0/25 | 2/60 | 4/10 | 3/40 |
| PruritusSkin and subcutaneous tissue disorders | 11/68 | 72/293 | 5/25 | 15/60 | 2/10 | 16/40 |
| RashSkin and subcutaneous tissue disorders | 12/68 | 64/293 | 2/25 | 16/60 | 2/10 | 15/40 |
| NauseaGastrointestinal disorders | 13/68 | 70/293 | 4/25 | 19/60 | 2/10 | 14/40 |
| ConstipationGastrointestinal disorders | 9/68 | 43/293 | 5/25 | 9/60 | 3/10 | 12/40 |
| DiarrhoeaGastrointestinal disorders | 6/68 | 41/293 | 3/25 | 13/60 | 3/10 | 7/40 |
| White blood cell count decreasedInvestigations | 0/68 | 3/293 | 0/25 | 10/60 | 0/10 | 12/40 |
The population analyzed was treated participants. As it was pre-specified to assign treatment groups irrespective of dose level, or cohorts such as based on type of cancer or country of origin, participants were instead combined into treatment groups based on their unique combination of interventions. For dose escalation, it was pre-specifed that participants were combined into monotherapy or sequential treatment groups rather than separate dose levels
| Age, Continuous(Years) | Vibostolimab | Vibostolimab + Pembrolizumab | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide | Total |
|---|---|---|---|---|---|---|
| Mean | 63.1 ± 12.0 | 57.6 ± 12.0 | 58.5 ± 10.0 | 68.5 ± 9.0 | 66.2 ± 8.2 | 59.3 ± 12.0 |
| Sex: Female, Male(Participants) | Vibostolimab | Vibostolimab + Pembrolizumab | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide | Total |
|---|---|---|---|---|---|---|
| Female | 34 | 190 | 43 | 5 | 10 | 282 |
| Male | 34 | 103 | 17 | 5 | 30 | 189 |
| Ethnicity (NIH/OMB)(Participants) | Vibostolimab | Vibostolimab + Pembrolizumab | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 17 | 1 | 0 | 2 | 27 |
| Not Hispanic or Latino | 59 | 268 | 57 | 9 | 37 | 430 |
| Unknown or Not Reported | 2 | 8 | 2 | 1 | 1 | 14 |
| Race (NIH/OMB)(Participants) | Vibostolimab | Vibostolimab + Pembrolizumab | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) | Vibostolimab +Pembrolizumab+Pemetrexed+Carboplatin | Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 13 | 99 | 25 | 5 | 27 | 169 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 1 | 0 | 0 | 16 |
| White | 48 | 181 | 34 | 5 | 12 | 280 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 5 | 0 | 0 | 1 | 6 |
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