Pembrolizumab in combination with vibostolimab in relapsed or refractory hematologic malignancies

Phase 1

Active, not recruiting

• Conditions: Relapsed/refractory hematological malignancies; MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001700-15-IT
• Lead Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-27
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Cohort A
cHL
a) Diagnosis of cHL, according to the WHO classification
b) Relapsed or refractory cHL to at least 1 prior line of therapy
c) Not been previously treated with an anti-PD-1 or anti-PD-L1 therapy PMBCL
d) Diagnosis of PMBCL, according to the WHO classification
e) Relapsed or refractory PMBCL to at least 2 prior lines of therapies
f) Must have previously received rituximab as part of prior treatment
g) Not been previously treated with an anti-PD-1 or anti-PD-L1 therapy
2. Cohort B
cHL
a) Diagnosis of cHL, according to the WHO classification
b) Relapsed or refractory cHL to at least 2 prior lines of therapies
c) Have progressed on treatment with an anti-PD-1/L1 mAb
administered as monotherapy or with other checkpoint inhibitors or other therapies PMBCL

For other inclusion criteria please refer to the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1. For Cohort D and F (DLBCL and NHL): Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinema, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (- like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
2. For Cohort E (MM):
a) Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, monoclonal gammopathy of undetermined significance.
b) History of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
3. Has known prior or current CNS involvement.
4. A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
8. Has received prior therapy with an mAb blocking TIGIT or its coreceptors, or an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
9. Has received prior therapy with an anti-TIGIT agent.
10. Any PMBCL participants in Cohort A and B that require the use of urgent cytoreductive therapy.
11. Has received prior systemic anticancer therapy, including investigational agents, within 2 weeks (small molecules like kinase inhibitors) or 4 weeks (chemotherapies and monoclonal antibodies) before cohort allocation.

For other exclusion criteria please refer to the protocol.

Study & Design

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