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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Sep 2022 → 8 Jan 2026

Decision date (initial)

2023-08-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-503615-14-00

EudraCT number

2022-000371-39

WHO UTN

U1111-1287-5864

ClinicalTrials.gov

NCT05508867

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacoeconomic, Pharmacogenetic, Pharmacodynamic, Pharmacokinetic, Therapy, Efficacy, Pharmacogenomic

To compare MK-4280A to physician’s choice chemotherapy with respect to PFS per Lugano response criteria by investigator assessment

Secondary objectives 4

1. To evaluate MK-4280A to physician’s choice chemotherapy with respect to OS
2. To evaluate MK-4280A and physician’s choice chemotherapy with respect to ORR per Lugano response criteria by investigator assessment
3. To evaluate MK-4280A and physician’s choice chemotherapy with respect to DOR per Lugano response criteria by investigator assessment
4. To evaluate the safety and tolerability of MK-4280A

Conditions and MedDRA coding

Relapsed or Refractory Classical Hodgkin Lymphoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
2. 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
3. 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
4. Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

Exclusion criteria 14

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

1. Overall Survival (OS)
2. Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Investigator
3. Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
4. Number of Participants Who Experienced At Least One Adverse Event (AE)
5. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Pallavi Madhusoodhan Pillai

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Pallavi Madhusoodhan Pillai

Third parties 6

Locations

7 EU/EEA countries · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 91 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications