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Checkpoint Inhibitor
Vibostolimab + Pembrolizumab for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group performance status of 0 to 1
Females must not be pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
Study Summary
This trial is testing a new drug, vibostolimab, for safety and efficacy as a treatment for metastatic solid tumors. The drug will be tested as monotherapy and in combination with pembrolizumab or pembrolizumab plus pemetrexed and carboplatin. The primary hypotheses are that vibostolimab is safe and tolerable when administered at the recommended Phase 2 dose, and that the fixed dose of pembrolizumab/vibostolimab coformulation is safe and tolerable.
Who is the study for?
This trial is for adults with advanced solid tumors and no remaining treatment options expected to help. Participants must have measurable disease, be in good physical condition, not pregnant, agree to use contraception, and provide a tumor sample. Specific groups include Chinese from mainland China or Japanese descent with certain cancers who haven't had anti-PD-1/PD-L1 therapy.Check my eligibility
What is being tested?
The study tests vibostolimab alone and combined with pembrolizumab (with or without chemotherapy) in metastatic solid tumors. It aims to find the safest dose that can be given (RPTD), assess how the body processes these drugs, and evaluate their effectiveness against cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to immunotherapy agents like pembrolizumab/vibostolimab which could affect organs; infusion reactions; fatigue; digestive issues; blood disorders; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
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I am not pregnant.
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I have a metastatic solid tumor with no beneficial treatment options available.
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My cancer has spread and this was confirmed by a lab test.
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I have stage IV non-squamous NSCLC confirmed by tests.
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I have provided a sample of my tumor for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experienced At Least One Adverse Event (AE)
Number of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Area Under the Concentration-Time Curve
Maximum Plasma Concentration (Cmax)
Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)
+2 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposideExperimental Treatment5 Interventions
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.
Group II: vibostolimab Dose 2 Japanese cohortExperimental Treatment2 Interventions
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.
Group III: vibostolimab Dose 1 Japanese cohortExperimental Treatment2 Interventions
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.
Group IV: vibostolimab +pembrolizumab+pemetrexed+carboplatinExperimental Treatment4 Interventions
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.
Group V: vibostolimab + pembrolizumabExperimental Treatment2 Interventions
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.
Group VI: vibostolimabExperimental Treatment1 Intervention
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.
Group VII: pembrolizumab/vibostolimab coformulation China cohortExperimental Treatment1 Intervention
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.
Group VIII: pembrolizumab/vibostolimab coformulationExperimental Treatment1 Intervention
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.
Group IX: Randomized dose 2 comparison cohortExperimental Treatment2 Interventions
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.
Group X: Randomized dose 1 comparison cohortExperimental Treatment2 Interventions
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.
Group XI: Advanced solid tumor cohortExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
pemetrexed
2005
Completed Phase 3
~5000
carboplatin
2010
Completed Phase 3
~4790
cisplatin
1997
Completed Phase 3
~3290
etoposide
1994
Completed Phase 3
~9300
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,505 Total Patients Enrolled
5 Trials studying Tumors
149 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCLead Sponsor
3,906 Previous Clinical Trials
5,064,326 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,788 Previous Clinical Trials
8,065,560 Total Patients Enrolled
2 Trials studying Tumors
34 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can carry out all my usual activities without help.I am not pregnant.I stopped an immune therapy due to a severe side effect.I am taking high doses of steroids or other drugs that weaken my immune system.I have a metastatic solid tumor with no beneficial treatment options available.I cannot stop taking aspirin or NSAIDs, except for low-dose aspirin, for 5 to 8 days.I cannot or will not take folic acid or Vitamin B12 supplements.I am Chinese with a confirmed metastatic solid tumor and have had no more than 2 prior treatments.My cancer has spread and this was confirmed by a lab test.I have cancer that has spread to my brain or spinal cord.I am Japanese, living in Japan, with inoperable stomach cancer that has not improved after treatment.I have stage IV non-squamous NSCLC confirmed by tests.I am currently being treated for an infection.I have had pneumonitis treated with steroids.I have had a bone marrow or organ transplant.I am HIV positive or have active Hepatitis B or C.I have been treated with a drug targeting the TIGIT receptor before.I had cancer before, but it was treated successfully and has been gone for over 5 years.I will not need any cancer treatment other than the trial.I have not had a live virus vaccine in the last 30 days.I have provided a sample of my tumor for testing.I have interstitial lung disease.I have taken hormonal cancer therapy, like tamoxifen, within the last 4 weeks.I have fluid buildup in my abdomen or around my lungs.I agree to use birth control during the study.I still experience side effects from cancer treatment received over 4 weeks ago.I haven't had cancer treatment or major surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: vibostolimab Dose 2 Japanese cohort
- Group 2: Advanced solid tumor cohort
- Group 3: vibostolimab + pembrolizumab
- Group 4: vibostolimab Dose 1 Japanese cohort
- Group 5: pembrolizumab/vibostolimab coformulation
- Group 6: vibostolimab +pembrolizumab+pemetrexed+carboplatin
- Group 7: Randomized dose 1 comparison cohort
- Group 8: Randomized dose 2 comparison cohort
- Group 9: vibostolimab
- Group 10: vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
- Group 11: pembrolizumab/vibostolimab coformulation China cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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