CMP-001 + Pembrolizumab for Lymphoma

Overseen By Umar Farooq, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Umar Farooq

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Active infection, HIV, Hepatitis B, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of CMP-001 (an experimental treatment) combined with pembrolizumab for treating lymphoma, a type of blood cancer that recurs or resists treatment. The trial focuses on assessing the effectiveness and safety of this combination for patients. It seeks participants with Hodgkin or Non-Hodgkin Lymphoma who have a noticeable tumor suitable for injection with the study drug and have previously received treatments like anti-B cell therapy. Participants should manage daily symptoms effectively and be able to understand and follow the study's procedures. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received certain cancer therapies or live vaccines recently, and you should not be on high-dose steroids or other immunosuppressive treatments. 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 the combination of CMP-001 and pembrolizumab is generally well-tolerated. In studies with 63 patients, the most common side effects were manageable, including fever, nausea, vomiting, headache, and low blood pressure. While side effects can occur, they are usually not severe.

The safety profile appears manageable, indicating that the risks are not too high for most people. However, the treatment's safety is still under investigation in an ongoing early-phase trial, with scientists closely examining its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lymphoma?

Researchers are excited about CMP-001 combined with pembrolizumab for lymphoma because it offers a novel approach compared to standard treatments like chemotherapy and radiation. CMP-001 is an innovative drug that works by stimulating the immune system to attack cancer cells directly, a mechanism different from traditional therapies. Additionally, the combination with pembrolizumab, an immunotherapy drug known for blocking the PD-1 pathway, enhances the body's immune response against lymphoma. This dual-action approach has the potential to improve treatment outcomes and offer new hope for patients.

What evidence suggests that CMP-001 plus pembrolizumab could be effective for lymphoma?

Studies have shown that pembrolizumab effectively treats certain types of cancer, particularly those with highly mutated tumors or PD-L1 expression. This effectiveness has led to its approval for treating some cancers. In this trial, participants will receive a combination of CMP-001 and pembrolizumab. Research suggests that adding CMP-001 to pembrolizumab might improve outcomes for patients with recurrent or treatment-resistant lymphoma. Early findings indicate that this combination can lead to strong responses and help overcome resistance to pembrolizumab alone. These treatments enhance the immune system's ability to attack cancer cells. ^{4 6 7 8 9}

Who Is on the Research Team?

Umar Farooq, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

Adults with relapsed or refractory Hodgkin or Non-Hodgkin Lymphoma who've had prior B cell therapy are eligible. They must have measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception. Exclusions include lung disease requiring steroids, certain psychiatric/substance abuse disorders, recent other cancer treatments, live vaccines within a month, active infections like Hepatitis/HIV, autoimmune diseases treated within two years.

Inclusion Criteria

My cancer can be measured and has grown in previously treated areas.

I have given my written consent to participate and can follow the study's requirements.

I have had B cell therapy but my B cell count is sufficient or I've responded well to a test vaccine.

Exclusion Criteria

I have not received a live vaccine within the last 30 days.

- Hematological: Absolute neutrophil count (ANC) ≥1000/µL;Platelets ≥75 000/µL; Hemoglobin ≥8.0 g/dLa;

My organ function is not within the required range for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intratumoral administration of CMP-001 and intravenous administration of pembrolizumab

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CMP-001
• Pembrolizumab

Trial Overview The trial is testing CMP-001 combined with pembrolizumab for lymphoma patients who haven't responded well to previous treatments. It's an early phase trial aiming to find the right dose that works best while keeping side effects manageable.

How Is the Trial Designed?

Group I: CMP-001 plus pembrolizumab Experimental Treatment 2 Interventions

Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab

Who Is Running the Clinical Trial?

Umar Farooq

Lead Sponsor

Trials

1

Recruited

40+

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

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Checkmate Pharmaceuticals

Industry Sponsor

Trials

11

Recruited

520+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02680184

NCT02680184 | Clinical Study of CMP-001 in Combination ... The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6527794/

Clinical utility of pembrolizumab in the management of ... Pembrolizumab has already proven its efficacy and thus obtained marketing authorization in so-called hot or hypermutated tumors or tumors expressing PD-L1 such ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5452070/

Pembrolizumab KEYNOTE-001: an adaptive study leading ... These data supported accelerated approval of pembrolizumab 2 mg/kg Q3W for patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥50%) as determined by ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-08963

Pembrolizumab and CMP-001 for the Treatment of ... Giving pembrolizumab and CMP-001 together may work better than given pembrolizumab alone in treating patients with relapsed to refractory lymphoma. Eligibility ...

5. onclive.com onclive.com/view/cmp-001-plus-pembrolizumab-elicits-deep-responses-reverses-pd-1-resistance-in-advanced-melanoma

CMP-001 Plus Pembrolizumab Elicits Deep Responses ... Immunotherapy has significantly improved outcomes for patients with cancer, but most patients still do not respond to anti–PD-1/PD-L1 therapies.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03983668

CMP-001 for Relapsed and Refractory Lymphoma This study is a single-arm, open-label, phase I/II trial designed to find a CMP-001 dose that, in combination with pembrolizumab, has optimal clinical efficacy ...

7. oncpracticemanagement.com oncpracticemanagement.com/issues/2018/september-2018-vol-8-no-9/tlr9-agonist-plus-immunotherapy-may-overcome-resistance-to-pd-1-inhibition

TLR9 Agonist plus Immunotherapy May Overcome ... “Based on these preliminary findings, the combination of CMP-001 and pembrolizumab appears to have a manageable safety profile and meaningful clinical activity, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02680184

NCT02680184 | Clinical Study of CMP-001 in Combination ... The primary objective of the Treatment Extension is to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy in ...

9. healio.com healio.com/news/hematology-oncology/20180417/pembrolizumab-plus-cmp001-demonstrates-efficacy-for-antipd1-resistant-melanoma

Pembrolizumab plus CMP-001 demonstrates efficacy for ... Safety data were available from 63 patients. The most common manageable toxicities included fever, nausea/vomiting, headache, hypotension ...