Blinatumomab + Pembrolizumab for Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Matthew J. Wieduwilt

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult patients with relapsed or refractory B-lineage ALL (B-ALL). The primary objective of this study is to determine if the addition of pembrolizumab to blinatumomab improves the Complete Response Rate (CR) and Complete Remission with Partial Hematologic Recovery (CRh) relative to blinatumomab alone in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia with high bone marrow lymphoblast percentage (\>50% lymphoblasts).

Eligibility Criteria

Adults with relapsed or refractory B-cell acute lymphoblastic leukemia who have tried at least one therapy before can join. They must not be pregnant, agree to use birth control, and should not have had certain treatments or surgeries recently. People with heart issues, other cancers needing treatment, active infections like TB or hepatitis, HIV, recent vaccines, autoimmune diseases or lung problems are excluded.

Inclusion Criteria

My organs are working well.

I agree to use two forms of birth control or abstain from sex during and up to 120 days after the study.

I agree to use a condom during sex with women who can have children, from the start of the study until 120 days after it ends.

Exclusion Criteria

I had a stem cell transplant from a donor within the last 5 years.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

I have been diagnosed with Burkitt lymphoma/leukemia.

Participant Groups

The trial is testing if adding pembrolizumab to blinatumomab improves response in patients whose leukemia has returned after treatment or didn't respond to previous therapies. It's a two-part study: first part checks safety (Phase I) and second part measures effectiveness (Phase II).

Group I: Blinatumomab + Pembrolizumab Experimental Treatment 2 Interventions

Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle length 42 days Other Names: Blincyto Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Other Names: * Keytruda * MK-3475

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• High-risk first relapse BCP-ALL

🇺🇸 Approved in United States as Blincyto for:

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
• First or second complete remission with minimal residual disease (MRD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF Fresno Community Cancer Institute Clovis, CA

UCSF Comprehensive Cancer Center San Francisco, CA

UC Irvine Health Chao Family Comprehensive Cancer Center Orange, CA

UC San Diego Moores Cancer Center La Jolla, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

Matthew Wieduwilt, M.D., Ph.D. Lead Sponsor

Amgen Industry Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

References