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Monoclonal Antibodies

Favezelimab + Pembrolizumab for Lymphoma

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

Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening

Has measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis

Must not have

Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody

Has known clinically active central nervous system (CNS) involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of signing informed consent form (icf) until the end of follow-up (up to approximately 27 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of two drugs, favezelimab and pembrolizumab, when used alone or in combination to treat people with classical Hodgkin lymphoma, diffuse large B-cell lymphoma, and indolent non-Hodgkin lymphoma.

Who is the study for?

This trial is for people with certain blood cancers like Hodgkin's lymphoma and B-cell lymphoma. Participants must be relatively healthy (ECOG performance status of 0 or 1), have measurable disease, and can provide a recent tumor biopsy. They shouldn't have severe leftover side effects from past treatments, active infections, CNS involvement, recent vaccines or immunotherapies, HIV/hepatitis B/C infection, pregnancy/breastfeeding plans within the study period, or a history of LAG-3 antibody treatment.

What is being tested?

The trial tests Favezelimab combined with Pembrolizumab in non-randomized groups for some patients and as monotherapy in randomized groups for others with classical Hodgkin lymphoma. It has two phases: an initial phase to ensure safety by looking at dose-limiting toxicities and then an expansion phase to assess effectiveness.

What are the potential side effects?

Potential side effects may include immune-related reactions due to both drugs' action on the immune system which could lead to inflammation in various organs; infusion-related reactions; fatigue; possible increased risk of infections due to immunosuppression; and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

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

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I can provide a recent or new tumor biopsy for testing.

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I have a tumor that can be measured with a scan and is larger than 15mm long or 10mm wide.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have been treated with an anti-LAG-3 antibody before.

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My cancer has spread to my brain or spinal cord.

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I have had pneumonitis treated with steroids or have it now.

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I have received CAR-T-cell therapy for my cancer.

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I have an active hepatitis B or C infection.

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I have been diagnosed with HIV.

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I have had a stem cell or organ transplant in the last 5 years.

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I have lasting side effects from previous treatments that affect my daily activities.

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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

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I am currently receiving IV treatment for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of signing informed consent form (icf) until the end of follow-up (up to approximately 27 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of signing informed consent form (icf) until the end of follow-up (up to approximately 27 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of signing informed consent form (icf) until the end of follow-up (up to approximately 27 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

Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)

Percentage of Participants Experiencing an Adverse Event (AE)

Percentage of Participants with Treatment Discontinuations Due to an AE

Secondary study objectives

Objective Response Rate (ORR)

Serum Concentration of Favezelimab

Serum Concentration of Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B: iNHL-Combination TherapyExperimental Treatment2 Interventions

Participants with iNHL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group II: Part B: cHL-Combination TherapyExperimental Treatment2 Interventions

Participants with cHL receive 200 mg pembrolizumab by IV infusion followed by the recommended Phase 2 dose (RP2D) of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group III: Part B: Randomized cHL-MonotherapyExperimental Treatment2 Interventions

Participants with cHL receive either pembrolizumab by IV infusion or the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to approximately 2 years).

Group IV: Part B: DLBCL-Combination TherapyExperimental Treatment2 Interventions

Participants with DLBCL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group V: Part A: Favezelimab Dose C+PembrolizumabExperimental Treatment2 Interventions

Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose C by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group VI: Part A: Favezelimab Dose B+pembrolizumabExperimental Treatment2 Interventions

Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose B by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group VII: Part A: Favezelimab Dose A+pembrolizumabExperimental Treatment2 Interventions

Participants receive 200 mg pembrolizumab by intravenous (IV) infusion followed by favezelimab Dose A by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Favezelimab

2016

Completed Phase 1

~490

pembrolizumab

2017

Completed Phase 3

~5890