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Anti-tumor antibiotic

Immunotherapy for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease

Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB with measurable disease per investigator assessment

Must not have

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new immunotherapy drug in children and young adults with Hodgkin's Lymphoma who haven't responded well to other treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs (like lungs), infusion-related reactions which can range from mild discomfort to more serious symptoms during drug administration, fatigue, digestive problems including nausea or diarrhea, blood disorders like anemia or clotting issues, increased risk of infections due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been newly diagnosed with advanced Hodgkin lymphoma.

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I can do most activities but need help with some, whether I am under or over 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have or had lung inflammation that needed steroids.

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I am currently being treated for an infection.

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

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I have received cancer treatment, including experimental drugs, for my current diagnosis before being assigned to a treatment group.

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I have been diagnosed with lymphocyte-predominant Hodgkin Lymphoma.

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My cancer has spread to my brain or the linings of my brain.

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I have a severe allergy to one of the study drugs or their ingredients.

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I have been treated with specific immunotherapy or was in a pembrolizumab study.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator

Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR

Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bleomycin

2010

Completed Phase 1

~60

etoposide

1994

Completed Phase 3

~9300