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A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

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ClinicalTrials.gov Identifier: NCT05508867
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Biological: favezelimab/pembrolizumab Drug: bendamustine Drug: gemcitabine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
Actual Study Start Date : October 18, 2022
Estimated Primary Completion Date : May 25, 2027
Estimated Study Completion Date : June 16, 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Favezelimab/Pembrolizumab
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.
 Biological: favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Other Name: MK-4820A
Active Comparator: Chemotherapy (Bendamustine or Gemcitabine)
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.
 Drug: bendamustine
IV infusion
Other Name: BENDEKA®

Drug: gemcitabine
IV infusion
Other Name: GEMZAR®


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 43 months ]
    PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by BICR or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 105 months ]
    OS is defined as the time from randomization to death due to any cause.

  2. Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by BICR [ Time Frame: Up to approximately 25 months ]
    ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by BICR.

  3. Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR [ Time Frame: Up to approximately 43 months ]
    For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

  4. Number of Participants Who Experienced At Least One Adverse Event (AE) [ Time Frame: Up to approximately 27 months ]
    An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.

  5. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 24 months ]
    An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
  • Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
  • Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
  • Submits an archival (<5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

Exclusion Criteria:

  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
  • History of central nervous system (CNS) metastases or active CNS involvement.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic treatment.
  • History of hemophagocytic lymphohisticytosis.
  • Has an active seizure disorder that is not well controlled.
  • Has clinically significant (ie, active) cardiovascular disease.
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
  • Has not adequately recovered from major surgical procedure.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • History of human immunodeficiency virus (HIV).
  • Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05508867


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05508867    
Other Study ID Numbers: 4280A-008
MK-4280A-008 ( Other Identifier: Merck )
2023-503615-14 ( Registry Identifier: EU CT )
2022-000371-39 ( EudraCT Number )
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Pembrolizumab
 Bendamustine Hydrochloride
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents