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Monoclonal Antibodies

Pembrolizumab-Based Therapy for Hodgkin's Lymphoma

Phase 2
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants of any sex who are ≥60 years of age on day 1, cycle 1
Histologically confirmed diagnosis of classical Hodgkin lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new fitness-adapted regimen for previously untreated older patients with classical Hodgkin lymphoma. The first cycle of treatment will be with pembrolizumab and brentuximab vedotin, followed by an assessment of fitness. Those deemed "non-fit" will continue treatment with pembrolizumab and brentuximab vedotin for 3 more cycles, then will switch to single-agent pembrolizumab for 4 additional cycles. Those deemed "fit" will switch from brentuximab vedotin to concurrently-administered combination chemotherapy using doxor

Who is the study for?
This trial is for people over 60 with untreated classical Hodgkin lymphoma. They should be able to perform daily activities (ECOG status 0-2), have good organ function, and measurable disease. Prior radiation is okay under certain conditions, but no prior immune checkpoint inhibitors or systemic therapy for lymphoma except steroids.Check my eligibility
What is being tested?
The study tests a pembrolizumab-based treatment combined with brentuximab vedotin (BV) or chemotherapy drugs doxorubicin, vinblastine, and dacarbazine (AVD). Participants are assessed for fitness after initial treatment to determine their subsequent therapy path in this phase II trial.See study design
What are the potential side effects?
Possible side effects include infusion reactions from the drugs used, potential nerve damage (neuropathy), fatigue, allergic reactions to pembrolizumab's ingredients, pancreatitis risk increase, infection susceptibility due to immunosuppression from treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have been diagnosed with classical Hodgkin lymphoma.
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My cancer shows up on PET scans and is at least 1.5cm big.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Remission Rate
Therapeutic procedure
Secondary outcome measures
2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the fit older population following pembrolizumab-based adaptive therapy
Complete remission rate (LYRIC criteria) after lead-in BV/pembrolizumab
Complete remission rate (by LYRIC criteria), 2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the non-fit older population
+1 more
Other outcome measures
Incidence and Severity of treatment-related toxicities
Incidence of change in fitness assignment from baseline assessment.
Rate of Indeterminate Response (LYRIC criteria)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fit CohortExperimental Treatment4 Interventions
Three 6-week cycles of 400 mg intravenous pembrolizumab + intravenous AVD (q 2 weeks).
Group II: Non-Fit CohortActive Control2 Interventions
Three 6-week cycles of 400 mg intravenous pembrolizumab and concurrent (q 3 week) intravenous brentuximab vedotin (BV).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
FDA approved
Dacarbazine
FDA approved
Pembrolizumab
FDA approved
Doxorubicin
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,955 Total Patients Enrolled
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,996 Total Patients Enrolled

Media Library

Brentuximab vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05404945 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been cleared by the FDA?

"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence supporting its safety, there is no data indicating whether or not it is effective. Our team at Power gave it a score of 2."

Answered by AI

Are there any more slots open for willing participants in this research project?

"Yes, according to the information available on clinicaltrials.gov, this study is looking for 44 individuals to take part in the trial at a single location. The original posting was on 7/26/2022 and there was one update on 7/27/2022."

Answered by AI

What are the goals that this medical study is hoping to achieve?

"According to the sponsor of this trial, Merck Sharp & Dohme LLC, the primary outcome being measured over a period of 2 years is Complete Remission Rate. Additionally, this study will also assess secondary outcomes including but not limited to: remission rate after lead-in therapy, progression-free survival (PFS), overall survival (OS), and lymphoma specific survival in both the fit and non-fit older population."

Answered by AI
~29 spots leftby Oct 2027