Combination Therapy for Hodgkin's Lymphoma

Not yet recruiting at 5 trial locations

Overseen By Michael Spinner, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael Spinner, MD

Must not be taking: PD-1 inhibitors, Immunosuppressants

Disqualifiers: Pregnancy, Breastfeeding, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of four drugs to treat classic Hodgkin's lymphoma that hasn't responded to other treatments. The goal is to determine if these drugs can better manage the cancer, using a special blood test to track treatment effectiveness. Individuals with Hodgkin's lymphoma that has recurred or not responded after initial treatment might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain cancer treatments or participated in other studies recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a treatment combining pembrolizumab with gemcitabine, vinorelbine, and liposomal doxorubicin (known as P-GVD) has been tested for safety in people with relapsed or hard-to-treat Hodgkin lymphoma. In these studies, participants generally tolerated P-GVD well. Common side effects included tiredness, low blood cell counts, and nausea. These studies provide evidence that the treatment can be used safely in everyday medical practice. However, as with any treatment, some individuals might experience more serious side effects, so discussing these risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this combination therapy for Hodgkin's Lymphoma because it integrates innovative drugs like Pembrolizumab with traditional chemotherapy agents, potentially enhancing treatment effectiveness. Pembrolizumab is an immunotherapy that works by unleashing the immune system to better recognize and attack cancer cells, offering a different mechanism compared to standard chemotherapy regimens. The use of Liposomal Doxorubicin in the mix helps reduce side effects by targeting the drug more precisely to cancer cells. This combination aims to improve patient outcomes by targeting Hodgkin's Lymphoma through multiple pathways, potentially leading to better responses and fewer relapses.

What evidence suggests that this combination therapy could be effective for Hodgkin's Lymphoma?

In this trial, participants will receive a combination of pembrolizumab with gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) to treat classic Hodgkin lymphoma (cHL) that has returned or not responded to initial treatments. Research has shown that this combination is effective as a second-line treatment. Most patients tolerate it well, experiencing few serious side effects. This treatment can also prepare patients for more intensive therapies, such as high-dose therapy and stem cell transplants. Overall, pembrolizumab plus GVD shows promise for those facing challenging cases of Hodgkin lymphoma. ^{4 6 7 8 9}

Who Is on the Research Team?

Michael Spinner, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients with relapsed or refractory classic Hodgkin lymphoma. Participants must have specific forms of the disease and are likely to have undergone previous treatments that didn't work. Detailed eligibility criteria were not provided, so additional requirements may apply.

Inclusion Criteria

I am 18 years old or older.

My diagnosis is classic Hodgkin lymphoma.

At least one site of FDG-avid disease on PET/CT that is ≥ 1.5 cm in diameter for nodal disease or ≥ 1.0 cm in diameter if extranodal disease

Exclusion Criteria

Participation in a study of an investigational product within four weeks of the first dose of treatment

I haven't had cancer treatment or radiation in the last 2 weeks, or antibody therapy in the last 4 weeks.

My cancer worsened within 6 months after my last PD-1 inhibitor treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 cycles of pembrolizumab and GVD, with response assessment to determine eligibility for further treatment or consolidation

6 weeks

2 visits (in-person) per cycle

Consolidation

Eligible participants receive non-transplant consolidation with pembrolizumab and/or 30 Gy ISRT based on response

8 cycles

Follow-up

Participants are monitored for long-term efficacy and toxicity outcomes

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Liposomal Doxorubicin
• Pembrolizumab
• Vinorelbine

Trial Overview The study tests a combination of pembrolizumab, gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in treating Hodgkin lymphoma. It also uses ctDNA testing with Foresight CLARITY LDT to monitor response to treatment and detect minimal residual disease.

How Is the Trial Designed?

Group I: Treatment (Pembrolizumab + GVD) Experimental Treatment 8 Interventions

All participants receive 2, 21-day cycles of 200 mg Pembrolizumab (pembro) on day 1 of each cycle (pembro) and 1000mg Gemcitabine, 20mg/m\^2 of Vinorelbine, Liposomal doxorubicin 15 mg/m2 (GVD) on days 1 and 8 of each cycle for up to 2 cycles. Pegfilgrastim is administered on day 8 or 9 of each cycle. FDG-PET/CT imaging and Foresight CLARITY LDT ctDNA response after 2 cycles will determine if participants are eligible for an additional 2 cycles of pembro + GVD or salvage therapy and ASCT. Participants may be able to qualify for consolidation without ASCT (pembro and/or 30 Gy ISRT) depending on response. Radiographic response after 4 cycles will be conducted to determine eligibility for consolidation without ASCT for participants with CR or standard of care salvage therapy and ASCT, for participants with partial response (PR), stable disease (SD), or progressive disease (PD) after a second administration of pembro+GVD. Participants are followed for up to 5 years.

Who Is Running the Clinical Trial?

Michael Spinner, MD

Lead Sponsor

UC Hematologic Malignancies Consortium (UCHMC)

Collaborator

Foresight Diagnostics

Collaborator

Trials

1

Recruited

40+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34170745/

Phase II Trial of Pembrolizumab Plus Gemcitabine ... - PubMed Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.01056

Phase II Trial of Pembrolizumab Plus Gemcitabine ... Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03618550

Phase II Study of Second- Line Pembrolizumab Plus GVD ... The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.

4. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper200719.html

Paper: Pembrolizumab Gemcitabine Vinorelbine and ... Results: Patients and Treatment: We identified 65 CHL patients who received P-GVD between July 2019 and June 2024, including 43 who were treated ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118607669

624.Hodgkin Lymphoma and T/NK Cell ... In this phase II study, we aimed to establish the safety and efficacy of SLT with the PD-1 inhibitor, pembrolizumab, combined with the outpatient-administered ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9851707/

Phase II Trial of Pembrolizumab Plus Gemcitabine ... We conducted a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin (pembro-GVD) as second-line therapy for relapsed ...

7. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4431/529470/Pembrolizumab-Gemcitabine-Vinorelbine-and

Pembrolizumab Gemcitabine Vinorelbine and Liposomal ... Conclusions:This retrospective study confirms the utility of P-GVD in treating relapsed/refractory CHL in a real-world population. Though fewer ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124071891

Pembrolizumab Gemcitabine Vinorelbine and Liposomal ... This retrospective study confirms the utility of P-GVD in treating relapsed/refractory CHL in a real-world population.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-01802

Second-Line Pembrolizumab in Combination with ... This phase II trial studies the side effects and how well pembrolizumab in combination with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin ...