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MK7684A-004 - A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Prima/N linee, Seconda linea, Terza/N linea

Criteri di inclusione: 

- Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).

For PMBCL, DLBCL, FL, and MM:
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.

For DLBCL and NHL:
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.

For NHL:
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.

All participants:
- Have measurable disease.
- Have adequate organ function.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
- Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.

Criteri di esclusione: 

For DLBCL and NHL:
- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, 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.

For MM:
- Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
- Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Has known prior or current central nervous system (CNS) involvement.

For Epstein Barr virus (EBV) positive DLBCL:
- Associated with a solid organ transplant.

For all participants:
- A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Has a history of a second malignancy.
- Any PMBCL participants that require the use of urgent cytoreductive therapy.
- If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
- Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
- Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.

Trattamento sperimentale: 

vibostolimab (anti-TIGIT) + Pembrolizumab (MK-7684A)

Trattamento di controllo: 

NA

Note generali: 

Basket study
Cohort A: Have relapsedor refractory cHL to at least 1 prior line of therapy; Have relapsed or refractory PMBCL to at least 2 prior lines of therapies
Cohort B: Have relapsed or refractory cHL to at least 2 prior lines of therapies (including prior PD-1/L1 therapy); Have relapsed or refractory PMBCL to at least 3 prior lines of therapies (including prior PD-1/L1 therapy)
Cohort C: relapsed or refractory FL relapsed or refractory to at least 2 prior lines of therapy, chemoimmunotherapy and immunomodulatory agents (ie, lenalidomide + rituximab).
Cohort D: relapsed or refractory DLBCL progressed after at least 2 lines of previous therapy, including progression after an auto-SCT, or are not a candidate (per institutional criteria) for an auto-SCT.
Cohort E: relapsed or refractory must have failed their last line of therapy
Cohort F: relapsed or refractory NHL progressed after at least 2 lines of previous therapy

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Ematologia

Riferimento: Prof. Pierluigi Zinzani
Telefono: 0512143680
Email: pierluigi.zinzani@unibo.it

 

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
Ematologia

Riferimento: Dr.ssa Alessandra Tucci
Telefono: 0303995438
Email: alessandra.tucci@asst-spedalicivili.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Divisione Medicina Oncoematologica

Riferimento: Dr. Andrés Ferreri
Telefono: 0226437649
Email: ferreri.andres@hsr.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-001700-15

Data di inserimento: 10.05.2022

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

ASST Spedali Civili (Ematologia)

Riferimento: Dr.ssa Alessandra Tucci

Telefono: 0303995438

Email: alessandra.tucci@asst-spedalicivili.it

Localita: Brescia

 

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