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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug, pembrolizumab, to see if it is effective in treating Hodgkin lymphoma when combined with another drug, GVD.

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.Check my eligibility

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.See study design

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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My cancer returned or didn't respond after one chemotherapy treatment.

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My cancer came back or didn't respond to treatment, confirmed by a biopsy.

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I have been diagnosed with classical Hodgkin's lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Heart rate

Secondary outcome measures

Evaluate the 2-year PFS rate (part 2)

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894

12%

Weight decreased

Aspartate aminotransferase increased

Arthralgia

Constipation

Haemoptysis

Diarrhoea

Hypothyroidism

Decreased appetite

Alanine aminotransferase increased

Nasopharyngitis

Bronchitis

Anaemia

Cough

Asthenia

Pruritus

Pneumonia

Headache

Blood alkaline phosphatase increased

Rash

Leukopenia

Hyperglycaemia

Pneumonia bacterial

Myalgia

Subdural haemorrhage

Nausea

Malaise

White blood cell count decreased

Tumour associated fever

Upper respiratory tract infection

Hypertension

Pyrexia

Dyspnoea

Back pain

Chest pain

Haematemesis

Hyperthyroidism

Lymph gland infection

Upper gastrointestinal haemorrhage

Oedema peripheral

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab Second Course

Pembrolizumab

Chemotherapy (SOC 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

~3530

vinorelbine

2007

Completed Phase 4

~3050

pembrolizumab

2017

Completed Phase 3

~5750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,820 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,602 Total Patients Enrolled

Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

526 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned pembrolizumab for clinical use?

"The safety of pembrolizumab is rated at 2 on our scale, as this Phase 2 trial has evidence suggesting its safe but not yet any data proving efficacy."

Answered by AI

What is the aggregate number of individuals enrolled in this research endeavor?

"Affirmative, clinicaltrials.gov confirms that this research is actively recruiting participants who were initially posted on August 1st 2018 and last edited September 30th 2022. 69 patients need to be enrolled between 12 centers."

Answered by AI

What is the geographical reach of this experimental investigation?

"This ongoing medical experiment is distributed across a dozen sites: Basking Ridge, Harrison and Montvale among others. To reduce any travel constraints, you should prioritize the location nearest to your residence if you decide to partake in this research effort."

Answered by AI

To what extent has pembrolizumab been explored in prior research?

"The initial testing of pembrolizumab took place at the Butterworth Campus in Spectrum Health Hospital, back in 1997. Since then there have been 1858 studies published and 1718 trials actively recruiting participants right now; a vast majority are located near Basking Ridge, New york."

Answered by AI

Is this investigation the inaugural study of its kind?

"Since its first trial in 1997, sponsored by Alfacell, pembrolizumab has been studied extensively across 3876 cities and 84 countries. There are currently 1718 active studies related to this drug which received Phase 3 approval after the initial 300-participant study."

Answered by AI

Are there still opportunities for individuals to participate in this research endeavor?

"Affirmative, according to clinicaltrials.gov this medical experiment is recruiting now. It was first made available on August 1st 2018 and has been reviewed as recently as September 30th 2022. 69 subjects need to be recruited from 12 different sites."

Answered by AI

In what cases is pembrolizumab typically recommended?

"Pembrolizumab is frequently used to manage malignant melanoma of skin, as well as Kaposi's sarcoma AIDS-related disease, recurrent cervical cancer and locally advanced non-small cell lung carcinomas."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma

Moskowitz, Alison J., Gunjan Shah, Heiko Schöder, Nivetha Ganesan, Esther Drill, Helen Hancock, Theresa Davey, et al.. 2021. “Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01056.

Journal of Clinical OncologyJournal

Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma

clinicaltrials.govStudy

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

2018. "Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03618550.