← Back to Search

Other

Pembrolizumab + GVD for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Alison Moskowitz, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of 0 or 1 on the ECOG Performance Scale
Be ≥ 18 years of age on day of signing informed consent
Must not have
Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the combination of pembrolizumab and GVD chemotherapy in patients with Hodgkin lymphoma. Pembrolizumab boosts the immune system to fight cancer, and GVD directly kills cancer cells. Pembrolizumab has shown effectiveness in treating classical Hodgkin lymphoma, especially in patients who have relapsed after initial treatments.

Who is the study for?
Adults with classical Hodgkin's lymphoma that has returned or didn't respond after one multi-agent chemotherapy can join. They must have good heart function, no pregnancy, adequate organ function, and agree to use contraception. Excluded are those with more than one prior treatment, active CNS metastases, certain medical conditions or infections, recent live vaccines, a history of pneumonitis requiring steroids, or an organ transplant.
What is being tested?
The trial is testing the effectiveness and safety of pembrolizumab combined with GVD (gemcitabine, vinorelbine, liposomal doxorubicin) as a second-line treatment for relapsed or refractory Hodgkin lymphoma. Participants will receive this combination therapy to see how well it works compared to previous treatments.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs (like lungs causing pneumonitis), infusion-related reactions from the drugs being administered into the bloodstream and typical chemotherapy-associated effects like fatigue, blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Select...
My cancer returned or didn't respond after one chemotherapy treatment.
Select...
My cancer came back or didn't respond to treatment, confirmed by a biopsy.
Select...
I have been diagnosed with classical Hodgkin's lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had more than one treatment for Hodgkin Lymphoma.
Select...
I have not received a live vaccine within the last 30 days.
Select...
I do not have active HIV, Hepatitis B, or Hepatitis C.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Select...
I am currently being treated for an infection.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have cancer that has spread to my brain or spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate
Secondary study objectives
Evaluate the 2-year PFS rate (part 2)

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Bronchitis
9%
Haemoptysis
9%
Constipation
9%
Aspartate aminotransferase increased
9%
Diarrhoea
9%
Decreased appetite
9%
Arthralgia
9%
Nasopharyngitis
9%
Alanine aminotransferase increased
9%
Hypothyroidism
6%
Asthenia
6%
Headache
6%
Anaemia
6%
Cough
6%
Pruritus
6%
Blood alkaline phosphatase increased
6%
Pneumonia
3%
Back pain
3%
Subdural haemorrhage
3%
Tumour associated fever
3%
Dyspnoea
3%
Upper respiratory tract infection
3%
Leukopenia
3%
Oedema peripheral
3%
Nausea
3%
Pyrexia
3%
Lymph gland infection
3%
Hyperglycaemia
3%
Malaise
3%
Rash
3%
Upper gastrointestinal haemorrhage
3%
Myalgia
3%
Chest pain
3%
White blood cell count decreased
3%
Hypertension
3%
Haematemesis
3%
Pneumonia bacterial
3%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: pembrolizumab plus GVDExperimental Treatment5 Interventions
Part 1: Patients will receive 2-4 cycles of pembrolizumab plus GVD Part 2: up to 40 patients will be enrolled onto an expansion cohort. On the expansion, patients who achieve CR to 4 cycles of pembro-GVD will receive 13 cycles of pembrolizumab maintenance (instead of HDT/ASCT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
liposomal doxorubicin
2009
Completed Phase 3
~600
gemcitabine
2013
Completed Phase 3
~4260
vinorelbine
2007
Completed Phase 4
~3050
pembrolizumab
2017
Completed Phase 3
~6070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hodgkin's Lymphoma include PD-1 inhibitors and cytotoxic chemotherapy. PD-1 inhibitors, such as pembrolizumab, block the PD-1 pathway, which cancer cells use to evade the immune system, thereby enhancing the body's ability to recognize and destroy cancer cells. Cytotoxic chemotherapy agents, like those in the GVD regimen (gemcitabine, vinorelbine, and doxorubicin), work by damaging the DNA of cancer cells, preventing their division and leading to cell death. This combination of immunotherapy and chemotherapy can potentially improve treatment outcomes by utilizing both the immune system's targeting capabilities and the direct cell-killing effects of chemotherapy.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,963 Previous Clinical Trials
597,327 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,978 Previous Clinical Trials
5,177,960 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
527 Total Patients Enrolled
~7 spots leftby Aug 2025