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Monoclonal Antibodies

Pembrolizumab Combinations for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL), advanced melanoma, solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high (TMB-H)

Be younger than 65 years old

Must not have

Known additional malignancy that is progressing or has required active treatment within the past 1 year

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 57 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test a drug called pembrolizumab in combination with other drugs in children with certain types of cancer. The study will have two parts: the first part will focus on safety and

Who is the study for?

This trial is for young people with certain blood cancers or solid tumors that haven't responded to other treatments. Participants must have recovered from side effects of previous cancer therapies and have specific diagnoses like relapsed Hodgkin lymphoma, advanced melanoma, or tumors with high mutational burden.

What is being tested?

The study tests Pembrolizumab in combination with new drugs (Vibostolimab, Favezelimab) on pediatric patients. It has two parts: first ensuring the treatment is safe and finding the right dose, then checking how well it works. Patients are placed into either part based on what's currently available.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms, fatigue, digestive issues, skin rash and changes in blood counts which could lead to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is one of: relapsed Hodgkin lymphoma, advanced melanoma, MSI-H/dMMR, or TMB-H solid tumors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that has not needed treatment in the last year.

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I have active brain metastases or carcinomatous meningitis.

Select...

I am currently being treated for an infection.

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I am HIV-positive with a history of Kaposi's sarcoma or Castleman's Disease.

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I have been treated with specific immunotherapy drugs for cancer.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I am experiencing or being treated for GVHD.

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I am still recovering from major surgery or have complications.

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My cancer has spread to the brainstem.

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I had radiotherapy less than 2 weeks ago or need steroids for radiation side effects.

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I have both Hepatitis B and C infections.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have had a transplant of tissue or an organ from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 57 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 57 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 57 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Area Under the Curve (AUC)

Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough)

Part 1: Maximum Concentration (Cmax)

+5 more

Secondary study objectives

Part 2: Area Under the Curve (AUC)

Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough)

Part 2: Maximum Concentration (Cmax)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention

Participants will receive coformulated pembrolizumab/vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.

Group II: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions

Participants will receive pembrolizumab and vibostolimab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.

Group III: Favezelimab/PembrolizumabExperimental Treatment1 Intervention

Participants will receive coformulated favezelimab/pembrolizumab via an IV infusion Q3W for up to 35 cycles. Each cycle is 21 days.

Group IV: Favezelimab + PembrolizumabExperimental Treatment2 Interventions

Participants will receive pembrolizumab and favezelimab via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles. Each cycle is 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Favezelimab

2016

Completed Phase 1

~490