Immunotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+93 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.

Eligibility Criteria

This trial is for children and young adults with classical Hodgkin Lymphoma who are slow to respond to initial chemotherapy. They must have measurable disease, adequate organ function, and agree to specific contraception if applicable. Exclusions include severe allergies to study drugs, certain heart conditions, prior treatments with similar agents or vaccines close to the start of the trial, active infections like HIV or hepatitis, and other health issues that could interfere.

Inclusion Criteria

I have been newly diagnosed with early-stage classical Hodgkin Lymphoma without bulky disease.

I have been newly diagnosed with advanced Hodgkin lymphoma.

I am a male and agree to not donate sperm and follow the study's rules on sexual activity and contraception.

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Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

I have had a solid organ transplant or a bone marrow transplant in the last 5 years.

I have another cancer that is getting worse or needed treatment in the last 3 years.

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Treatment Details

Interventions

Bleomycin (Anti-tumor antibiotic)
Cyclophosphamide (Alkylating agents)
Dacarbazine (Alkylating agents)
Doxorubicin (Anthracyclines)
Etoposide (Topoisomerase II inhibitors)
Pembrolizumab (Monoclonal Antibodies)
Prednisone/Prednisolone (Corticosteroid)
Vinblastine (Vinca alkaloids)
Vincristine (Vinca alkaloids)

Trial OverviewThe trial tests pembrolizumab combined with standard chemotherapy in patients who haven't responded well initially. It aims to see how safe this combination is and how effective it is at treating Hodgkin Lymphoma in these particular patients.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + COPDAC-28 (Group 2)Experimental Treatment8 Interventions

After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m\^2 on Days 1 and 8, vincristine 1.5 mg/m\^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m\^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m\^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.

Group II: Pembrolizumab + AVD (Group 1)Experimental Treatment6 Interventions

After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2 and dacarbazine 375 mg/m\^2 on Days 1 and 15; cycle frequency every 4 weeks \[Q4W\]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.

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

🇪🇺 Approved in European Union as Bleomycin for: