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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Objective Response Rate (ORR)
Serum Concentration of Favezelimab
Serum Concentration of Pembrolizumab
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
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,497 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,961 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,570 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an anti-LAG-3 antibody before.My cancer has spread to my brain or spinal cord.I have another cancer besides skin or early cervical cancer, and it's getting worse or needs treatment.I have had pneumonitis treated with steroids or have it now.I can provide a recent or new tumor biopsy for testing.I have received CAR-T-cell therapy for my cancer.I have not received a live vaccine in the last 30 days.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I have an active hepatitis B or C infection.I have been diagnosed with HIV.I have had a stem cell or organ transplant in the last 5 years.I have a tumor that can be measured with a scan and is larger than 15mm long or 10mm wide.I have lasting side effects from previous treatments that affect my daily activities.I have not had cancer treatment or chest radiation in the last 14 days.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have an autoimmune disease treated with strong medication in the last 2 years.I am currently receiving IV treatment for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: cHL-Combination Therapy
- Group 2: Part A: Favezelimab Dose A+pembrolizumab
- Group 3: Part B: DLBCL-Combination Therapy
- Group 4: Part B: Randomized cHL-Monotherapy
- Group 5: Part A: Favezelimab Dose C+Pembrolizumab
- Group 6: Part B: iNHL-Combination Therapy
- Group 7: Part A: Favezelimab Dose B+pembrolizumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being included in this clinical exploration?
"Affirmative. Records on clinicaltrials.gov state that this research program, which was initially posted on October 17th 2018, is presently enrolling participants. A total of 174 patients will be accepted from 9 distinct sites."
Answered by AI
To what medical conditions does Favezelimab typically provide relief?
"Favezelimab is a viable treatment for malignant neoplasms and can also be used to manage unresectable melanoma, microsatellite instability high cases, or those with disease progression after chemotherapy."
Answered by AI
What other research has illuminated the potential of Favezelimab?
"As of now, 961 Favezelimab clinical trials are ongoing, with 122 in Phase 3. Houston is a major hub for this treatment research; however, there are 35727 sites running these experiments worldwide."
Answered by AI
Are there any openings in this research project for participants?
"Affirmative, the most recent information posted on clinicaltrials.gov confirms that this medical research is currently recruiting patients. This trial was initially listed on October 17th 2018 and updated recently on October 13th 2022; it intends to fill 174 positions at 9 distinct sites."
Answered by AI
How many clinical locations are supervising the trial?
"Nine clinical sites are recruiting patients, such as City of Hope in Duarte (Site 0001), Pacific Cancer Care in Monterey ( Site 0006) and BC Cancer in Vancouver (Site 0107). Additionally, there are six other locations that have openings."
Answered by AI
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