Pembrolizumab + Chemotherapy for B-Cell Lymphoma

Overseen By Justin Kline, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Pregnancy, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will research untreated non-germinal center diffuse large B cell lymphoma and what causes the disease and the way patients respond to pembrolizumab combined with R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) therapy.

Research Team

Justin Kline, MD

Principal Investigator

University of Chicago Medicine

Eligibility Criteria

Adults with untreated non-germinal center diffuse large B cell lymphoma or high-grade B cell lymphoma, not pregnant or breastfeeding, willing to use contraception. Must have measurable disease and adequate organ function. Cannot have had prior anti-lymphoma therapy or certain other treatments, no active infections like HIV or hepatitis, and no history of severe hypersensitivity to trial drugs.

Inclusion Criteria

- Not a woman of childbearing potential (WOCBP) OR

I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.

I agree to use contraception and not donate sperm for 120 days after my last treatment dose.

Exclusion Criteria

I have previously undergone treatment for lymphoma.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

I have a history of Hepatitis B or an active Hepatitis C infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab in combination with R-CHOP chemotherapy regimen

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

23 months

Treatment Details

Interventions

• Pembrolizumab
• R-CHOP Protocol

Trial Overview The study is testing the effectiveness of pembrolizumab combined with R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in treating patients with specific types of B cell lymphoma that haven't been treated before.

Participant Groups

Group I: Treatment Arm Experimental Treatment 2 Interventions

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

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University