MK-4280A versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, relapsed/refractory Classical Hodgkin Lymphoma

Phase 1

Recruiting

• Conditions: Relapsed or Refractory Classical Hodgkin Lymphoma; MedDRA version: 20.1Level: LLTClassification code: 10080208Term: Classical Hodgkin lymphoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503615-14-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 314

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., 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., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare MK-4280A to physician’s choice chemotherapy with respect to PFS per Lugano response criteria by BICR.;Secondary Objective: To compare MK-4280A to physician’s choice chemotherapy with respect to OS., To evaluate MK-4280A and physician’s choice chemotherapy with respect to ORR per Lugano response criteria by BICR., To evaluate MK-4280A and physician’s choice chemotherapy with respect to DOR per Lugano response criteria by BICR., To evaluate the safety and tolerability of MK-4280A.;Primary end point(s): Progression-Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Overall Survival (OS);Secondary end point(s):Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by BICR;Secondary end point(s):Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR;Secondary end point(s):Number of Participants Who Experienced At Least One Adverse Event (AE);Secondary end point(s):Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)