340 Participants Needed

Immunotherapy for Hodgkin's Lymphoma

Recruiting at 93 trial locations
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Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of pembrolizumab.

Is immunotherapy for Hodgkin's Lymphoma safe for humans?

In studies of treatments for Hodgkin's Lymphoma, some patients experienced lung problems from bleomycin, with a 24% occurrence in older patients and an 18% death rate from this issue. Overall, treatment-related death was higher in older patients (9%) compared to younger ones (0.3%).12345

How is the drug regimen for Hodgkin's Lymphoma unique?

This drug regimen combines multiple chemotherapy agents, including bleomycin, cyclophosphamide, dacarbazine, doxorubicin, etoposide, prednisone, vinblastine, and vincristine, which are used in various combinations like ABVD and BEACOPP. These combinations are known for their effectiveness in treating Hodgkin's Lymphoma, with ABVD being a standard treatment due to its lower toxicity and reduced risk of long-term side effects compared to other regimens.24678

What data supports the effectiveness of the drug combination used in the Immunotherapy for Hodgkin's Lymphoma trial?

Research shows that combinations like ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) are effective in treating Hodgkin's lymphoma, with high remission and survival rates. These combinations include many of the same drugs used in the trial, suggesting potential effectiveness.29101112

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.
See 3 more

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.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive two 4-week cycles of ABVD or OEPA induction therapy

8 weeks

Treatment

Participants receive pembrolizumab in combination with AVD or COPDAC-28 chemotherapy

8-16 weeks

Radiotherapy

Participants receive radiotherapy based on PET scan results after chemotherapy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 8 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bleomycin
  • Cyclophosphamide
  • Dacarbazine
  • Doxorubicin
  • Etoposide
  • Pembrolizumab
  • Prednisone/Prednisolone
  • Vinblastine
  • Vincristine
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab + COPDAC-28 (Group 2)Experimental Treatment8 Interventions
Group II: Pembrolizumab + AVD (Group 1)Experimental Treatment6 Interventions

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

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Approved in European Union as Bleomycin for:
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Approved in United States as Bleomycin for:
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Approved in Canada as Bleomycin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

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

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

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

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Published Research Related to This Trial

The OEPA-COPDAC chemotherapy regimen, which replaces procarbazine with etoposide and dacarbazine, was found to be tolerable in terms of toxicity for boys with Hodgkin's lymphoma, with hematotoxicity being less pronounced compared to the traditional COPP regimen.
After a median follow-up of 58.6 months, the overall survival rate was 97.4% and the event-free survival rate was 89.0%, indicating that OEPA-COPDAC is as effective as the standard OPPA-COPP regimen for treating intermediate and advanced stages of classical Hodgkin's lymphoma in pediatric patients.
Procarbazine-free OEPA-COPDAC chemotherapy in boys and standard OPPA-COPP in girls have comparable effectiveness in pediatric Hodgkin's lymphoma: the GPOH-HD-2002 study.Mauz-Körholz, C., Hasenclever, D., Dörffel, W., et al.[2022]
Etoposide is a key drug in treating malignant lymphomas and Hodgkin's disease, showing broad activity across various subtypes and demonstrating single-agent efficacy comparable to older treatments like alkylating agents and doxorubicin.
The drug works by inhibiting protein synthesis and topoisomerase II, allowing it to provide effective cytotoxicity without cross-resistance, and is integrated into multiple treatment protocols, enhancing the overall management of these cancers.
The evolving role of etoposide in the management of lymphomas and Hodgkin's disease.O'Reilly, SE., Klimo, P., Connors, JM.[2019]
In a study involving 856 adult patients with advanced Hodgkin's disease, both ABVD and MOPP/ABV regimens showed similar rates of complete remission and overall survival, indicating their effectiveness as initial chemotherapy treatments.
However, MOPP/ABV was associated with higher rates of acute pulmonary and hematologic toxicities, as well as a greater incidence of myelodysplastic syndromes (MDS) and leukemia, suggesting that ABVD is the safer and preferred treatment option.
Randomized comparison of ABVD and MOPP/ABV hybrid for the treatment of advanced Hodgkin's disease: report of an intergroup trial.Duggan, DB., Petroni, GR., Johnson, JL., et al.[2022]

Citations

Procarbazine-free OEPA-COPDAC chemotherapy in boys and standard OPPA-COPP in girls have comparable effectiveness in pediatric Hodgkin's lymphoma: the GPOH-HD-2002 study. [2022]
ABVD versus modified stanford V versus MOPPEBVCAD with optional and limited radiotherapy in intermediate- and advanced-stage Hodgkin's lymphoma: final results of a multicenter randomized trial by the Intergruppo Italiano Linfomi. [2015]
Risk-adapted BEACOPP regimen can reduce the cumulative dose of chemotherapy for standard and high-risk Hodgkin lymphoma with no impairment of outcome. [2021]
The evolving role of etoposide in the management of lymphomas and Hodgkin's disease. [2019]
Randomized comparison of ABVD and MOPP/ABV hybrid for the treatment of advanced Hodgkin's disease: report of an intergroup trial. [2022]
ChlVPP/PABlOE and radiotherapy in advanced Hodgkin's disease. The Central Lymphoma Group. [2017]
The efficacy and tolerability of adriamycin, bleomycin, vinblastine, dacarbazine and Stanford V in older Hodgkin lymphoma patients: a comprehensive analysis from the North American intergroup trial E2496. [2021]
Efficacy and safety of front-line treatments for advanced Hodgkin lymphoma: a systematic literature review. [2021]
Randomized Phase III Trial Comparing ABVD Plus Radiotherapy With the Stanford V Regimen in Patients With Stages I or II Locally Extensive, Bulky Mediastinal Hodgkin Lymphoma: A Subset Analysis of the North American Intergroup E2496 Trial. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Chemoresistance as a function of the pretherapy tumor burden and the chemotherapy regimen administered: differences observed with 2 current chemotherapy regimens for advanced Hodgkin lymphoma. [2011]
Treatment of stage I and II Hodgkin's lymphoma with ABVD chemotherapy: results after 7 years of a prospective study. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Six cycles of ABVD in the treatment of stage I and II Hodgkin's lymphoma: a pilot study. [2017]
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