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Completed

NCT Number: NCT05508867

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)

Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Aleman-oncohematologic diseases ( Site 2302), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

favezelimab/pembrolizumab

Biological

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Other names: MK-4820A

Bendamustine

Drug

IV infusion

Other names: BENDEKA®

Gemcitabine

Drug

IV infusion

Other names: GEMZAR®

Primary outcomes

  1. Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator

    Time frame: Up to approximately 39 months

    PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 39 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 investigator

    Time frame: Up to approximately 39 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 investigator.

  3. Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator

    Time frame: Up to approximately 39 months

    For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, 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 25 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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