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Active, not recruitingNCT04895722Updated Jul 2, 2026Results posted

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).

A Phase 2 interventional study of Pembrolizumab and Pembrolizumab/Quavonlimab in Colorectal Cancer, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 109 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
302
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Death-Ligand 1 (PDL1, PD-L1)
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 302 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
  • Has locally confirmed dMMR/MSI-H
  • Has a life expectancy of at least 3 months
  • Female participants are eligible to participate if not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP), or if a WOCBP then uses a contraceptive method that is highly effective or is abstinent on a long-term and persistent basis, during the intervention period and for at least 120 days after the last dose of study intervention
  • Has measurable disease per RECIST 1.1 as assessed by the site and verified by BICR
  • Submit an archival (within 5 years of Screening) or newly obtained tumor tissue sample that has not been previously irradiated; formalin-fixed, paraffin embedded (FFPE) blocks are preferred to slides.
  • Has adequate organ function

Cohort A:

- Has been previously treated for their Stage IV dMMR/MSI-H CRC and radiographically progressed on or after or could not tolerate standard treatment, which must include all of the following agents if approved and locally available in the country where the participant is randomized:

  • Fluoropyrimidine, irinotecan and oxaliplatin (capecitabine is acceptable as equivalent to fluorouracil in prior therapy)
  • With or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (e.g., bevacizumab)
  • At least one of the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for rat sarcoma viral oncogene homolog (RAS) wild-type participants with left-sided tumors. Prior EGFR therapy is optional for patients with right sided RAS Wild-type (WT) tumors.

Cohort B:

- Has untreated Stage IV dMMR/MSI-H CRC with no prior chemotherapy or immunotherapy for this disease

Exclusion criteria

Exclusion Criteria:

  • Has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Has not recovered adequately from a surgery procedure, and/or has any complications from a prior surgery before starting study intervention
  • Has received prior radiotherapy within 2 weeks of start of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830, and/or any of their excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
  • Has a history of acute or chronic pancreatitis
  • Has neuromuscular disorders associated with an elevated creatine kinase
  • Has urine protein ≥1 gram/24 hours
  • Has an active infection requiring systemic therapy (e.g., tuberculosis, known viral or bacterial infections, etc.)
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Concurrent active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable Hepatitis B Virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid [RNA] infection
  • Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
  • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before randomization/allocation
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Has had an allogenic tissue/solid organ transplant
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
302 participants (actual)

Study arms

  • Experimental
    Cohort A - Pembrolizumab/Quavonlimab

    Participants in Cohort A receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.

    Biological: Pembrolizumab/Quavonlimab

  • Active comparator
    Cohort A - Pembrolizumab

    Participants in Cohort A receive pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.

    Biological: Pembrolizumab

  • Experimental
    Cohort B - Pembrolizumab/Quavonlimab

    Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.

    Biological: Pembrolizumab/Quavonlimab

  • Experimental
    Cohort B - Pembrolizumab Plus MK-4830

    Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.

    Biological: Pembrolizumab · Biological: MK-4830

  • Experimental
    Cohort B - Pembrolizumab/Favezelimab

    Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.

    Biological: Pembrolizumab/Favezelimab

  • Experimental
    Cohort B - Pembrolizumab/Vibostolimab

    Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.

    Biological: Pembrolizumab/Vibostolimab

  • Active comparator
    Cohort B - Pembrolizumab

    Participants in Cohort B receive pembrolizumab 400 mg IV Q6W for up to approximately 2 years.

    Biological: Pembrolizumab

Interventions

  • BiologicalPembrolizumab

    400 mg or 200 mg pembrolizumab administered via IV infusion.

    Also known as: MK-3475, Keytruda®

  • BiologicalPembrolizumab/Quavonlimab

    Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.

    Also known as: MK-1308A

  • BiologicalPembrolizumab/Favezelimab

    Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion

    Also known as: MK-4280A

  • BiologicalPembrolizumab/Vibostolimab

    Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion

    Also known as: MK-7684A

  • BiologicalMK-4830

    800 mg MK-4830 administered via IV infusion

06

What researchers measure

Primary outcomes

  1. 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 have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR is presented.

    Time frame: Up to approximately 46 months

Secondary outcomes

  1. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR as assessed by BICR is presented.

    Time frame: Up to approximately 46 months

  2. Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

    PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR is presented.

    Time frame: Up to approximately 46 months

  3. PFS Per RECIST 1.1 as Assessed by Investigator

    PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator is presented.

    Time frame: Up to approximately 46 months

  4. ORR Per RECIST 1.1 as Assessed by Investigator

    ORR was defined as the percentage of participants who had a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by investigator is be presented.

    Time frame: Up to approximately 46 months

  5. DOR Per RECIST 1.1 as Assessed by Investigator

    DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator is presented.

    Time frame: Up to approximately 46 months

  6. Overall Survival (OS)

    OS was defined as the time from randomization (or first dose) to death due to any cause. OS is presented.

    Time frame: Up to approximately 46 months

  7. Number of Participants Who Experienced an 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 intervention. The number of participants with an AE is presented.

    Time frame: Up to approximately 60 months

  8. 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 intervention. The number of participants that discontinue study treatment due to an AE is presented.

    Time frame: Up to approximately 60 months

07

Results

Posted Jun 8, 2026

Participant flow

Participant flow — Overall Study
MilestoneCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
Started60613920404141
Treated60603920404141
Received second course treatment1300000
Completed0000000
Not completed60613920404141
Withdrew: Death223011611911
Withdrew: Physician decision0000120
Withdrew: Sponsor decision0000340
Withdrew: Withdrawal by subject1012100
Withdrew: Participant ongoing in trial37312712242630

Outcome measures

PrimaryObjective 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 have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR is presented.

Time frame:
Up to approximately 46 months
Reported as:
Number · Percentage of Participants
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)
Percentage of ParticipantsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
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)45.0 (32.1 to 58.4)29.5 (18.5 to 42.6)46.2 (30.1 to 62.8)65.0 (40.8 to 84.6)37.5 (22.7 to 54.2)48.8 (32.9 to 64.9)41.5 (26.3 to 57.9)
Statistical analysis
  • Cohort A - Pembrolizumab/Quavonlimab vs Cohort A - Pembrolizumab · Difference in percentage: 15.6 · 95% CI -1.7 to 32.1Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Difference in percentage: 4.6 · 95% CI -16.9 to 25.7Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab Plus MK-4830 vs Cohort B - Pembrolizumab · Difference in percentage: 23.4 · 95% CI -3.7 to 46.7Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Favezelimab vs Cohort B - Pembrolizumab · Difference in percentage: -3.8 · 95% CI -24.4 to 17.1Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Difference in percentage: 7.3 · 95% CI -14.0 to 28.0Based on Miettinen \& Nurminen method stratified by RAS mutation.
SecondaryDuration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR as assessed by BICR is presented.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
MonthsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICRNA (NA to NA)NA (33.7 to NA)NA (NA to NA)NA (20.8 to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
SecondaryProgression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR is presented.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
MonthsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR17.9 (4.2 to NA)4.2 (2.2 to 14.6)NA (12.0 to NA)NA (2.2 to NA)8.3 (2.3 to NA)24.7 (8.3 to NA)NA (4.2 to NA)
Statistical analysis
  • Cohort A - Pembrolizumab/Quavonlimab vs Cohort A - Pembrolizumab · Hazard ratio (hr): 0.65 · 95% CI 0.41 to 1.02Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.78 · 95% CI 0.39 to 1.56Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab Plus MK-4830 vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.77 · 95% CI 0.33 to 1.81Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Favezelimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 1.18 · 95% CI 0.62 to 2.26Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Vibostolimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.78 · 95% CI 0.38 to 1.58Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
SecondaryPFS Per RECIST 1.1 as Assessed by Investigator

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator is presented.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
PFS Per RECIST 1.1 as Assessed by Investigator
MonthsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
PFS Per RECIST 1.1 as Assessed by Investigator9.4 (4.2 to 31.3)6.2 (2.2 to 33.4)24.7 (10.3 to NA)NA (3.0 to NA)5.6 (2.1 to 26.9)24.7 (8.2 to NA)20.8 (4.1 to NA)
Statistical analysis
  • Cohort A - Pembrolizumab/Quavonlimab vs Cohort A - Pembrolizumab · Hazard ratio (hr): 0.81 · 95% CI 0.52 to 1.27Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.83 · 95% CI 0.43 to 1.62Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab Plus MK-4830 vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.71 · 95% CI 0.30 to 1.70Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Favezelimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 1.55 · 95% CI 0.85 to 2.83Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Vibostolimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.83 · 95% CI 0.43 to 1.62Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
SecondaryORR Per RECIST 1.1 as Assessed by Investigator

ORR was defined as the percentage of participants who had a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by investigator is be presented.

Time frame:
Up to approximately 46 months
Reported as:
Number · Percentage of Participants
ORR Per RECIST 1.1 as Assessed by Investigator
Percentage of ParticipantsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
ORR Per RECIST 1.1 as Assessed by Investigator41.7 (29.1 to 55.1)27.9 (17.1 to 40.8)46.2 (30.1 to 62.8)60.0 (36.1 to 80.9)40.0 (24.9 to 56.7)53.7 (37.4 to 69.3)43.9 (28.5 to 60.3)
Statistical analysis
  • Cohort A - Pembrolizumab/Quavonlimab vs Cohort A - Pembrolizumab · Difference in percentage: 13.9 · 95% CI -3.1 to 30.2Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Difference in percentage: 2.2 · 95% CI -19.4 to 23.6Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab Plus MK-4830 vs Cohort B - Pembrolizumab · Difference in percentage: 16.2 · 95% CI -10.7 to 40.4Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Favezelimab vs Cohort B - Pembrolizumab · Difference in percentage: -3.8 · 95% CI -24.8 to 17.5Based on Miettinen \& Nurminen method stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Vibostolimab vs Cohort B - Pembrolizumab · Difference in percentage: 9.8 · 95% CI -11.7 to 30.3Based on Miettinen \& Nurminen method stratified by RAS mutation.
SecondaryDOR Per RECIST 1.1 as Assessed by Investigator

DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator is presented.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
DOR Per RECIST 1.1 as Assessed by Investigator
MonthsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
DOR Per RECIST 1.1 as Assessed by InvestigatorNA (NA to NA)35.3 (33.4 to NA)NA (NA to NA)NA (NA to NA)25.0 (10.3 to NA)NA (NA to NA)NA (18.7 to NA)
SecondaryOverall Survival (OS)

OS was defined as the time from randomization (or first dose) to death due to any cause. OS is presented.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsCohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - Pembrolizumab
Overall Survival (OS)NA (29.0 to NA)37.1 (14.4 to NA)NA (NA to NA)NA (6.9 to NA)NA (21.2 to NA)NA (NA to NA)NA (21.2 to NA)
Statistical analysis
  • Cohort A - Pembrolizumab/Quavonlimab vs Cohort A - Pembrolizumab · Hazard ratio (hr): 0.70 · 95% CI 0.41 to 1.21Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Quavonlimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.99 · 95% CI 0.43 to 2.29Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab Plus MK-4830 vs Cohort B - Pembrolizumab · Hazard ratio (hr): 1.17 · 95% CI 0.45 to 3.07Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Favezelimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 1.02 · 95% CI 0.45 to 2.32Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
  • Cohort B - Pembrolizumab/Vibostolimab vs Cohort B - Pembrolizumab · Hazard ratio (hr): 0.80 · 95% CI 0.33 to 1.95Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by RAS mutation.
SecondaryNumber of Participants Who Experienced an 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 intervention. The number of participants with an AE is presented.

Time frame:
Up to approximately 60 months

Results for this outcome have not been posted.

SecondaryNumber 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 intervention. The number of participants that discontinue study treatment due to an AE is presented.

Time frame:
Up to approximately 60 months

Results for this outcome have not been posted.

Adverse events

Collected over Up to approximately 46 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A: Pembrolizumab/Quavonlimab First Course23/60 (38.3%)17/60 (28.3%)52/60 (86.7%)
Cohort A: Pembrolizumab First Course30/61 (49.2%)12/60 (20%)47/60 (78.3%)
Cohort B: Pembrolizumab/Quavonlimab11/39 (28.2%)14/39 (35.9%)34/39 (87.2%)
Cohort B: Pembrolizumab Plus MK-48307/20 (35%)3/20 (15%)20/20 (100%)
Cohort B: Pembrolizumab/Favezelimab12/40 (30%)14/40 (35%)34/40 (85%)
Cohort B: Pembrolizumab/Vibostolimab9/41 (22%)13/41 (31.7%)38/41 (92.7%)
Cohort B: Pembrolizumab11/41 (26.8%)13/41 (31.7%)32/41 (78%)
Cohort A: Pembrolizumab/Quavonlimab Second Course0/1 (0%)1/1 (100%)1/1 (100%)
Cohort A: Pembrolizumab Second Course0/3 (0%)1/3 (33.3%)3/3 (100%)
Most frequent serious events
Showing 10 of 93
Most frequent serious events
EventCohort A: Pembrolizumab/Quavonlimab First CourseCohort A: Pembrolizumab First CourseCohort B: Pembrolizumab/QuavonlimabCohort B: Pembrolizumab Plus MK-4830Cohort B: Pembrolizumab/FavezelimabCohort B: Pembrolizumab/VibostolimabCohort B: PembrolizumabCohort A: Pembrolizumab/Quavonlimab Second CourseCohort A: Pembrolizumab Second Course
NephropathyRenal and urinary disorders1/600/600/390/200/400/410/411/10/3
Intestinal obstructionGastrointestinal disorders1/601/600/390/200/400/413/410/11/3
Large intestinal stenosisGastrointestinal disorders0/601/600/390/200/400/410/410/11/3
BacteraemiaInfections and infestations0/600/600/392/200/400/410/410/10/3
IleusGastrointestinal disorders0/600/600/390/203/400/410/410/10/3
Myocardial infarctionCardiac disorders3/600/600/390/200/400/410/410/10/3
Biliary tract infectionInfections and infestations0/600/600/391/200/400/410/410/10/3
Infusion related reactionInjury, poisoning and procedural complications0/600/600/390/202/400/410/410/10/3
DeathGeneral disorders1/600/601/390/200/402/410/410/10/3
GastroenteritisInfections and infestations0/600/600/390/200/402/410/410/10/3
Most frequent other events
Showing 10 of 72
Most frequent other events
EventCohort A: Pembrolizumab/Quavonlimab First CourseCohort A: Pembrolizumab First CourseCohort B: Pembrolizumab/QuavonlimabCohort B: Pembrolizumab Plus MK-4830Cohort B: Pembrolizumab/FavezelimabCohort B: Pembrolizumab/VibostolimabCohort B: PembrolizumabCohort A: Pembrolizumab/Quavonlimab Second CourseCohort A: Pembrolizumab Second Course
AnaemiaBlood and lymphatic system disorders16/6011/608/395/205/408/418/411/10/3
ThrombocytopeniaBlood and lymphatic system disorders1/602/600/390/200/402/410/411/10/3
NauseaGastrointestinal disorders4/604/606/391/203/405/414/411/10/3
AstheniaGeneral disorders4/608/607/391/204/402/415/410/13/3
FatigueGeneral disorders12/604/609/392/205/408/416/411/10/3
Urinary tract infectionInfections and infestations1/602/602/392/200/401/412/411/10/3
Lower limb fractureInjury, poisoning and procedural complications1/600/600/390/200/400/410/411/10/3
Skin abrasionInjury, poisoning and procedural complications1/600/600/390/200/400/410/411/10/3
Amylase increasedInvestigations5/600/600/390/202/402/413/411/10/3
Blood alkaline phosphatase increasedInvestigations3/604/603/390/205/401/412/411/10/3

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - PembrolizumabTotal
Mean59.6 ± 11.958.4 ± 12.960.1 ± 13.964.5 ± 12.757.3 ± 16.558.1 ± 15.564.2 ± 14.359.9 ± 14.0
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - PembrolizumabTotal
Female21251710202218133
Male39362210201923169
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - PembrolizumabTotal
Hispanic or Latino4762661041
Not Hispanic or Latino56523217323128248
Unknown or Not Reported021124313
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - PembrolizumabTotal
American Indian or Alaska Native323023720
Asian10125713644
Native Hawaiian or Other Pacific Islander00000000
Black or African American10000012
White45442913353324223
More than one race132022313
Unknown or Not Reported00000000
RAS Mutation Status
RAS Mutation Status(Participants)Cohort A - Pembrolizumab/QuavonlimabCohort A - PembrolizumabCohort B - Pembrolizumab/QuavonlimabCohort B - Pembrolizumab Plus MK-4830Cohort B - Pembrolizumab/FavezelimabCohort B - Pembrolizumab/VibostolimabCohort B - PembrolizumabTotal
RAS Mutant2525148151515117
RAS Wildtype35362512252626185
08

Study locations

109 sites
  • Mid Florida Cancer Center ( Site 1519)
    Orange City, Florida 32763, United States
  • University Cancer & Blood Center, LLC ( Site 1521)
    Athens, Georgia 30607, United States
  • University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
    Chicago, Illinois 60637, United States
  • Icahn School of Medicine at Mount Sinai ( Site 1528)
    New York, New York 10029, United States
  • Hematology Oncology Associates of Rockland ( Site 1525)
    Nyack, New York 10960, United States
  • UPMC Hillman Cancer Center ( Site 1516)
    Pittsburgh, Pennsylvania 15232, United States
  • The West Clinic, PLLC dba West Cancer Center ( Site 1576)
    Germantown, Tennessee 38138, United States
  • Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
    Nashville, Tennessee 37232, United States
  • UT Southwestern Medical Center ( Site 1551)
    Dallas, Texas 75390, United States
  • Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
    Temple, Texas 76508, United States
  • Northwest Medical Specialties, PLLC ( Site 1546)
    Tacoma, Washington 98405, United States
  • UZ Brussel ( Site 0105)
    Brussels, Bruxelles-Capitale, Region de 1090, Belgium
  • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)
    Brussels, Bruxelles-Capitale, Region de 1200, Belgium
  • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)
    Yvoir, Namur 5530, Belgium
  • UZ Leuven ( Site 0101)
    Leuven, Vlaams-Brabant 3000, Belgium
  • AZ Delta vzw ( Site 0106)
    Roeselare, West-Vlaanderen 8800, Belgium
  • The Moncton Hospital-Oncology ( Site 0307)
    Moncton, New Brunswick E1C 6Z8, Canada
  • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316)
    Toronto, Ontario M4N 3M5, Canada
  • McGill University Health Centre-CIM - Oncology ( Site 0306)
    Montreal, Quebec H4A 3J1, Canada
  • Instituto de Cancerología ( Site 1610)
    Medellín, Antioquia 050025, Colombia
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)
    Medellín, Antioquia 050030, Colombia
  • Clinica de la Costa S.A.S. ( Site 1608)
    Barranquilla, Atlántico 080020, Colombia
  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611)
    Bogotá, Bogota D.C. 111321, Colombia
  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)
    Valledupar, Cesar Department 200001, Colombia
  • Oncomédica S.A.S ( Site 1602)
    Montería, Departamento de Córdoba 230002, Colombia
  • Mediservis del Tolima IPS S.A.S ( Site 1609)
    Ibague, Tolima Department 730006, Colombia
  • CIMCA-Hemato-Oncology ( Site 2101)
    San José, Provincia de San José 1000, Costa Rica
  • Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)
    Santa Ana, Provincia de San José 10903, Costa Rica
  • Rigshospitalet ( Site 1904)
    Copenhagen, Capital Region 2100, Denmark
  • Regionshospitalet Gødstrup ( Site 1901)
    Herning, Central Jutland 7400, Denmark
  • Aalborg Universitetshospital, Syd ( Site 1903)
    Aalborg, North Denmark 9000, Denmark
  • Odense Universitetshospital ( Site 1902)
    Odense, Region Syddanmark 5000, Denmark
  • North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)
    Tallinn, Harju 13419, Estonia
  • Tartu University Hospital ( Site 2302)
    Tartu, Tartu 50406, Estonia
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et
    Marseille, Bouches-du-Rhone 13385, France
  • Centre Georges François Leclerc ( Site 0506)
    Dijon, Cote-d Or 21079, France
  • CHU Rangueil-Digestive oncology department ( Site 0502)
    Toulouse, Haute-Garonne 31059, France
  • Hopital Claude Huriez - CHU de Lille ( Site 0510)
    Lille, Nord 59037, France
  • Centre Hospitalier Universitaire de Poitiers ( Site 0511)
    Poitiers, Vienne 86021, France
  • Hôpital Saint Antoine-Oncologie médicale ( Site 0508)
    Paris, 75571, France
  • Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)
    Munich, Bavaria 81737, Germany
  • Universitätsklinikum Marburg ( Site 0610)
    Marburg, Hesse 35043, Germany
  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)
    Essen, North Rhine-Westphalia 45136, Germany
  • Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)
    Dresden, Saxony 01307, Germany
  • Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie
    Magdeburg, Saxony-Anhalt 39120, Germany
  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)
    Berlin, 10117, Germany
  • Asklepios Altona-Oncology ( Site 0602)
    Hamburg, 22763, Germany
  • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704)
    Athens, Attica 115 28, Greece
  • Evgenidion Hospital ( Site 2702)
    Athens, Attica 115 28, Greece
  • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)
    Heraklion, Irakleio 715 00, Greece
  • European Interbalkan Medical Center-Oncology Department ( Site 2701)
    Thessaloniki, 57001, Greece
  • CELAN,S.A ( Site 2202)
    Guatemala City, 01010, Guatemala
  • INTEGRA Cancer Institute-Oncology ( Site 2201)
    Guatemala City, 01010, Guatemala
  • MEDI-K CAYALA ( Site 2205)
    Guatemala City, 01016, Guatemala
  • Centro Regional de Sub Especialidades Médicas SA ( Site 2204)
    Quetzaltenango, 09001, Guatemala
  • Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)
    Quetzaltenango, 09002, Guatemala
  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009)
    Pécs, Baranya 7624, Hungary
  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)
    Kecskemét, Bács-Kiskun county 6000, Hungary
  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)
    Szolnok, Jász-Nagykun-Szolnok 5000, Hungary
  • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)
    Kaposvár, Somogy County 7400, Hungary
  • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)
    Budapest, 1088, Hungary
  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)
    Debrecen, 4032, Hungary
  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)
    Milan, Lombardy 20133, Italy
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)
    Naples, 80131, Italy
  • Istituto Oncologico Veneto IRCCS ( Site 0804)
    Padova, 35128, Italy
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)
    Kaunas, Kaunas County 50161, Lithuania
  • National Cancer Institute ( Site 2401)
    Vilnius, Vilniaus Miestas 08660, Lithuania
  • VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)
    Vilnius, 08460, Lithuania
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)
    Amsterdam, North Holland 1066CX, Netherlands
  • DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)
    Wroclaw, Lower Silesian Voivodeship 53-413, Poland
  • Luxmed Onkologia sp. z o. o. ( Site 0915)
    Warsaw, Masovian Voivodeship 01-748, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
    Warsaw, Masovian Voivodeship 02-034, Poland
  • Mrukmed-Mrukmed ( Site 0901)
    Rzeszów, Podkarpackie Voivodeship 35-021, Poland
  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)
    Koszalin, West Pomeranian Voivodeship 75-581, Poland
  • Powiatowe Centrum Zdrowia ( Site 0911)
    Brzeziny, Łódź Voivodeship 95-060, Poland
  • Spitalul de Oncologie Monza Oncologie Medicala ( Site 2601)
    Bucharest, Bucharest 013812, Romania
  • Fundeni Clinical Institute-Medical Oncology ( Site 2603)
    Bucharest, Bucharest 022328, Romania
  • Cardiomed SRL Cluj-Napoca ( Site 2602)
    Cluj-Napoca, Cluj 400015, Romania
  • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)
    Craiova, Dolj 200542, Romania
  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)
    Saint Petersburg, Leningradskaya Oblast' 198255, Russia
  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy
    Moscow, Moscow 115478, Russia
  • First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl
    Moscow, Moscow 119991, Russia
  • Rostov Cancer Research Institute ( Site 1014)
    Rostov-on-Don, Rostov Oblast 344037, Russia
  • GBUZ SPb CRPCstmc(o) ( Site 1005)
    Saint Petersburg, Sankt-Peterburg 197758, Russia
  • Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)
    Kazan', Tatarstan, Respublika 420029, Russia
  • Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)
    Daegu, Taegu-Kwangyokshi 41404, South Korea
  • Korea University Anam Hospital ( Site 1107)
    Seoul, 02841, South Korea
  • Seoul National University Hospital-Internal Medicine ( Site 1101)
    Seoul, 03080, South Korea
  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)
    Seoul, 03722, South Korea
  • Asan Medical Center-Department of Oncology ( Site 1105)
    Seoul, 05505, South Korea
  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)
    Seoul, 06351, South Korea
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)
    Seoul, 06591, South Korea
  • Hospital Universitario Marqués de Valdecilla ( Site 1202)
    Santander, Cantabria 39008, Spain
  • Hospital Universitari Vall d'Hebron ( Site 1201)
    Barcelona, Catalonia 08035, Spain
  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)
    Madrid, Madrid, Comunidad de 28007, Spain
  • H.R.U Malaga - Hospital General ( Site 1207)
    Málaga, Malaga 29010, Spain
  • COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210)
    Pamplona, Navarre 31009, Spain
  • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)
    Oviedo, Principality of Asturias 33011, Spain
  • Fundación Instituto Valenciano de Oncología ( Site 1209)
    Valencia, Valenciana, Comunitat 46009, Spain
  • Hospital Clinico San Carlos-Oncology Department ( Site 1204)
    Madrid, 28040, Spain

Showing the first 100 of 109 sites across 22 countries.

09

References and documents

Publications

  • Andre T, Pietrantonio F, Avallone A, Gumus M, Wyrwicz L, Kim JG, Yalcin S, Kwiatkowski M, Lonardi S, Zolnierek J, Odeleye-Ajakaye A, Leconte P, Fogelman D, Kim TW. KEYSTEP-008: phase II trial of pembrolizumab-based combination in MSI-H/dMMR metastatic colorectal cancer. Future Oncol. 2023 Dec;19(37):2445-2452. doi: 10.2217/fon-2022-1105. Epub 2023 Sep 13. PubMed 37701986 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 28, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04895722
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 20, 2021
Start date
Jun 25, 2021
Primary completion
May 21, 2025
Completion
Aug 6, 2026 (estimated)
Results posted
Jun 8, 2026
Last update
Jul 2, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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