A Phase 2 interventional study of Pembrolizumab/Quavonlimab and Lenvatinib in Advanced Hepatocellular Carcinoma, sponsored by Merck Sharp & Dohme LLC. Completed at 40 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed.
32 studies on the registry are indexed under Diabetes Mellitus, Insulin-Dependent, 12; 14 are open to participants now.
This study's enrollment of 116 is above the median of 64 across 30 interventional studies indexed under Diabetes Mellitus, Insulin-Dependent, 12.
Browse Diabetes Mellitus, Insulin-Dependent, 12 studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.
Biological: Pembrolizumab/Quavonlimab · Drug: Lenvatinib · Biological: Pembrolizumab
Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
Also known as: MK-1308A
Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
Also known as: MK-7902
Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.
Also known as: MK-3475, KEYTRUDA®
Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting \>7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for \>1 week (or bilirubin if persists \>4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \>10.0 times upper limit of normal (ULN) or \>10.0 times baseline if baseline \>ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
Time frame: 3 weeks
Number of Participants With ≥1 Adverse Event (AE)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported.
Time frame: Up to approximately 44 months
Number of Participants With ≥1 Serious Adverse Event (SAE)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
Time frame: Up to approximately 44 months
Number of Participants With ≥1 Immune-related AE (irAE)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported.
Time frame: Up to approximately 44 months
Number of Participants With ≥1 Hepatic AE
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT \<2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT \>3 × the Baseline level; ALT \>500 U/L regardless of baseline level; total bilirubin \>3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for \>3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported.
Time frame: Up to approximately 44 months
Number of Participants Discontinuing Study Treatment Due to an AE
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
Time frame: Up to approximately 40 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
Time frame: Up to approximately 51 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Time frame: Up to approximately 51 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
Time frame: Up to approximately 51 months
Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Time frame: Up to approximately 51 months
Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
Time frame: Up to approximately 51 months
Overall Survival (OS)
OS was defined as the time from the first dose of study intervention to death due to any cause.
Time frame: Up to approximately 51 months
ORR Per Modified RECIST (mRECIST) as Assessed by BICR
ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
Time frame: Up to approximately 51 months
DOR Per mRECIST as Assessed by BICR
For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
Time frame: Up to approximately 51 months
DCR Per mRECIST as Assessed by BICR
DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
Time frame: Up to approximately 51 months
PFS Per mRECIST as Assessed by BICR
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
Time frame: Up to approximately 51 months
TTP Per mRECIST as Assessed by BICR
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented.
Time frame: Up to approximately 51 months
| Milestone | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Started | 116 |
| Treated with pembrolizumab/quavonlimab + lenvatinib | 115 |
| Switched over to pembrolizumab + lenvatinib | 5 |
| Completed | 0 |
| Not completed | 116 |
| Withdrew: Death | 89 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Randomized by mistake without study treatment | 1 |
| Withdrew: Sponsor decision | 23 |
| Withdrew: Withdrawal by subject | 2 |
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting \>7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for \>1 week (or bilirubin if persists \>4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \>10.0 times upper limit of normal (ULN) or \>10.0 times baseline if baseline \>ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase | 0 |
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants With ≥1 Adverse Event (AE) | 114 |
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants With ≥1 Serious Adverse Event (SAE) | 52 |
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants With ≥1 Immune-related AE (irAE) | 55 |
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT \<2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT \>3 × the Baseline level; ALT \>500 U/L regardless of baseline level; total bilirubin \>3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for \>3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants With ≥1 Hepatic AE | 17 |
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
| Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Number of Participants Discontinuing Study Treatment Due to an AE | 31 |
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
| Percentage of Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | 38.3 (29.4 to 47.8) |
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | 12.4 (6.4 to 14.6) |
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
| Percentage of Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR | 79.1 (70.6 to 86.1) |
PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | 8.2 (6.2 to 10.2) |
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR | 8.5 (6.4 to 11.2) |
OS was defined as the time from the first dose of study intervention to death due to any cause.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Overall Survival (OS) | 21.0 (15.7 to 26.0) |
ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
| Percentage of Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| ORR Per Modified RECIST (mRECIST) as Assessed by BICR | 51.3 (41.8 to 60.7) |
For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| DOR Per mRECIST as Assessed by BICR | 10.0 (6.6 to 12.6) |
DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
| Percentage of Participants | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| DCR Per mRECIST as Assessed by BICR | 81.7 (73.5 to 88.3) |
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| PFS Per mRECIST as Assessed by BICR | 7.2 (6.2 to 9.2) |
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented.
| Months | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| TTP Per mRECIST as Assessed by BICR | 8.2 (6.2 to 10.4) |
Collected over Up to approximately 51 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab/Quavonlimab + Lenvatinib | 86/116 (74.1%) | 52/115 (45.2%) | 113/115 (98.3%) |
| Switched Over to MK-3475 + Lenvatinib | 4/5 (80%) | 1/5 (20%) | 5/5 (100%) |
| Event | Pembrolizumab/Quavonlimab + Lenvatinib | Switched Over to MK-3475 + Lenvatinib |
|---|---|---|
| Immune thrombocytopeniaBlood and lymphatic system disorders | 0/115 | 1/5 |
| COVID-19 pneumoniaInfections and infestations | 2/115 | 1/5 |
| Rotavirus infectionInfections and infestations | 0/115 | 1/5 |
| Immune-mediated encephalitisNervous system disorders | 0/115 | 1/5 |
| Immune-mediated enterocolitisGastrointestinal disorders | 6/115 | 0/5 |
| MalaiseGeneral disorders | 2/115 | 0/5 |
| PyrexiaGeneral disorders | 2/115 | 0/5 |
| CholangitisHepatobiliary disorders | 2/115 | 0/5 |
| PneumoniaInfections and infestations | 2/115 | 0/5 |
| Acute kidney injuryRenal and urinary disorders | 2/115 | 0/5 |
| Event | Pembrolizumab/Quavonlimab + Lenvatinib | Switched Over to MK-3475 + Lenvatinib |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 45/115 | 3/5 |
| AnaemiaBlood and lymphatic system disorders | 13/115 | 2/5 |
| Oedema peripheralGeneral disorders | 15/115 | 2/5 |
| Weight decreasedInvestigations | 22/115 | 2/5 |
| HypertensionVascular disorders | 43/115 | 2/5 |
| Decreased appetiteMetabolism and nutrition disorders | 36/115 | 0/5 |
| Aspartate aminotransferase increasedInvestigations | 31/115 | 1/5 |
| FatigueGeneral disorders | 29/115 | 1/5 |
| AstheniaGeneral disorders | 27/115 | 0/5 |
| ProteinuriaRenal and urinary disorders | 27/115 | 0/5 |
The baseline analysis population consisted of all allocated participants.
| Age, Continuous(Years) | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Mean | 63.4 ± 10.8 |
| Sex: Female, Male(Participants) | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Female | 21 |
| Male | 95 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 110 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Pembrolizumab/Quavonlimab + Lenvatinib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 53 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 59 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
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