Pembrolizumab for Non-Hodgkin's Lymphoma

Overseen By Ajay K. Gopal

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, Active TB, Autoimmune, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of pembrolizumab, a type of immunotherapy, for individuals with untreated B-cell non-Hodgkin's lymphoma. Pembrolizumab, a monoclonal antibody, may help the immune system attack cancer cells and inhibit their growth. The trial seeks participants with this cancer type who experience symptoms such as pain, fatigue, or night sweats. Participants will receive pembrolizumab intravenously every three weeks for up to 18 cycles, provided it remains effective and tolerable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research shows that pembrolizumab is generally well-tolerated by patients with non-Hodgkin lymphoma. Studies have found that while most patients experience some side effects, these are usually manageable. Common side effects include changes in blood cell counts.

In one study, 72.9% of patients experienced some side effects, but only 12.9% had more severe ones. Another study found that serious side effects occurred in 30% of patients, though these were less common. Overall, pembrolizumab has been used safely in other conditions, and evidence suggests it can be a safe option for many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pembrolizumab is unique because it harnesses the power of the immune system to fight non-Hodgkin's lymphoma by targeting the PD-1 pathway, a mechanism not typically utilized in traditional treatments like chemotherapy. This immunotherapy approach differs from standard options, which often involve broad-spectrum chemotherapy drugs that attack both cancerous and healthy cells. Researchers are excited about pembrolizumab because it offers a more targeted attack on cancer cells, potentially leading to fewer side effects and better outcomes for patients.

What evidence suggests that pembrolizumab might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that pembrolizumab, which participants in this trial will receive, may effectively treat non-Hodgkin's lymphoma. In one study, 22% of patients experienced a reduction or disappearance of their cancer. Other studies have reported even higher success rates, such as 69% and 58% in similar types of lymphoma. This treatment enhances the immune system's ability to identify and attack cancer cells. These findings suggest that pembrolizumab could be a promising option for treating non-Hodgkin's lymphoma. ^{1 3 4 6 7}

Who Is on the Research Team?

Ajay K. Gopal

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with untreated B-cell non-Hodgkin lymphoproliferative diseases who need treatment and have measurable disease. Participants must be in good physical condition (ECOG 0 or 1), not pregnant, willing to use birth control, and without serious health issues like active TB, HIV, certain cancers, CNS metastases, or severe autoimmune diseases.

Inclusion Criteria

My platelet count is at least 25,000/uL or my low count is due to bone marrow issues.

Be willing and able to provide written informed consent/assent for the trial

My lymphoma is getting worse over time.

Exclusion Criteria

I have been diagnosed with HIV.

I need urgent treatment for my lymphoma complications.

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab intravenously over 30 minutes on day 1, with treatment repeating every 3 weeks for up to 18 cycles

54 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

Trial Overview The study tests pembrolizumab's effectiveness on patients with specific types of lymphoma. Pembrolizumab is an immunotherapy drug that may help the immune system fight cancer by blocking a pathway tumors use to hide from it.

How Is the Trial Designed?

Group I: Treatment (pembrolizumab) Experimental Treatment 2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36398795/

Pembrolizumab for patients with non-Hodgkin lymphoma Primary end points were safety and objective response rate (ORR) per IWG 2007 criteria. Cohort 4 included 89 patients. ORR was 22% (19/86; 90% CI 15-31; 10 CR, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01953692

A Trial of Pembrolizumab (MK-3475) in Participants With ... The percentage of participants with complete remission as assessed by the investigator is presented. Up to approximately 78.5 months. Objective Response Rate ( ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/10428194.2022.2136956

Pembrolizumab for patients with non-Hodgkin lymphoma The median OS was 12.0 months (95% CI 6.0–22.5), the 2-year OS rate was 38%, and the 4-year OS rate was 29% ( Figure 3 ). For the one patient in ...

4. ashpublications.org ashpublications.org/blood/article/142/10/878/496370/Five-year-follow-up-of-KEYNOTE-087-pembrolizumab

Five-year follow-up of KEYNOTE-087: pembrolizumab ... The median OS was not reached (95% CI, 26.8-NR), and the 5-year OS rate was 53.7% (Figure 3C). Among the 33 patients with disease progression, ...

5. merck.com merck.com/news/keytruda-pembrolizumab-treatment-results-in-patients-with-relapsed-or-refractory-classical-hodgkin-lymphoma-chl-presented-at-58th-annual-meeting-of-the-american-society-of-hematology/

KEYTRUDA® (pembrolizumab) Treatment Results in ... In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall response rates (ORR) of 69.0 percent and 58 percent, respectively.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03407144

NCT03407144 | Safety and Efficacy of Pembrolizumab (MK ... This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed ...

7. merck.com merck.com/news/merck-announces-phase-3-trial-of-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-met-primary-endpoints/

Merck Announces Phase 3 Trial of Subcutaneous ... Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA; those ≥1% were pneumonitis, pneumonia, pyrexia, myocarditis, acute ...