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Monoclonal Antibodies
Favezelimab + Pembrolizumab for Hodgkin Lymphoma
Phase 3
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 105 months
Awards & highlights
Study Summary
This trial will compare a new combo drug to chemo for Hodgkin Lymphoma. It'll assess safety and efficacy for survival.
Who is the study for?
This trial is for adults with classical Hodgkin Lymphoma that's active despite previous treatments, including anti-PD-(L)1 therapy. They must have a confirmed diagnosis and provide tissue samples. Excluded are those with immunodeficiency, CNS metastases, active autoimmune diseases or infections, recent cancer therapies or surgeries, other malignancies within 3 years, HIV, or past organ transplants.Check my eligibility
What is being tested?
The study tests coformulated favezelimab/pembrolizumab against standard chemotherapy (bendamustine or gemcitabine) in patients whose lymphoma didn't respond to prior treatments. It aims to see if the new drug combo improves survival without disease progression compared to existing chemo options.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like lungs (pneumonitis), infusion-related symptoms such as fever and chills, fatigue, blood cell count changes increasing infection risk; specific side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 105 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 105 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experienced At Least One Adverse Event (AE)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Favezelimab/PembrolizumabExperimental Treatment1 Intervention
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.
Group II: Chemotherapy (Bendamustine or Gemcitabine)Active Control2 Interventions
Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,786 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,064,044 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My Hodgkin lymphoma is confirmed and shows up on special scans.I am still recovering from a major surgery.I have or had lung inflammation that needed steroids.I have another cancer that is getting worse or was treated in the last 3 years.I have seizures that are not well controlled.I have a history of HIV.I have an active heart condition.I haven't had radiotherapy or needed steroids for side effects in the last 2 weeks.I have had a stem cell or organ transplant in the last 5 years.I have a history of hemophagocytic lymphohistiocytosis.My cancer has worsened despite treatment with specific immune therapy.My cancer has spread to my brain or spinal cord.I have an immune system disorder or am on long-term steroids or other drugs that weaken my immune system.I am currently being treated for an infection.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I can provide a recent (less than 5 years old) tumor sample that hasn't been exposed to radiation.I have an autoimmune disease treated in the last 2 years, not including replacement therapy.My Hodgkin lymphoma has returned or didn't respond to treatment, and I've tried all known beneficial treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy (Bendamustine or Gemcitabine)
- Group 2: Favezelimab/Pembrolizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What potential risks and side effects can be associated with Favezelimab/Pembrolizumab use?
"Evidence suggests Favezelimab/Pembrolizumab is safe, so we rate it a 3 on our scale. This Phase 3 trial has yielded positive results regarding efficacy and safety thus far."
Answered by AI
Is the enrollment window for this experiment still open?
"The current status of this clinical trial, as can be seen on the official website (clinicaltrials.gov), is that it is actively enrolling participants. This research was initiated on October 18th 2022 and last updated March 31st 2023."
Answered by AI
Is the clinical trial for this project being conducted at multiple sites across America?
"Patients may receive this treatment from the University of Kentucky Chandler Medical Center in Lexington, Ohio; Cleveland Clinic-Taussig Cancer Center in Cleveland, Sao Paulo; Fundação Pio XII - Hospital de Câncer de Barretos in Barretos, Guangdong; and an additional 21 sites."
Answered by AI
How many individuals are actively engaged in this medical experiment?
"The sponsor of this trial, Merck Sharp & Dohme LLC, seeks 360 qualified participants from two locations in the US and one location in Sao Paulo. These include University of Kentucky Chandler Medical Center (Site 2201) in Lexington, Ohio and Cleveland Clinic-Taussig Cancer Center ( Site 2203) located within Cleveland as well as a medical centre situated in Sao Paulo."
Answered by AI
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