Ruxolitinib + Pembrolizumab for Lymphoma

Overseen By Seda Tolu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seda S. Tolu

Must be taking: Anti-retrovirals, HBV prophylaxis

Must not be taking: Immunosuppressants, Chronic steroids

Disqualifiers: ATLL, Autoimmune disease, Immunodeficiency, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining two drugs, ruxolitinib and pembrolizumab, can safely and effectively treat certain types of relapsed or stubborn lymphomas, including Hodgkin and non-Hodgkin types. The researchers aim to determine if adding ruxolitinib enhances the effectiveness of pembrolizumab for these specific cancers. Individuals who have tried at least one other treatment for their lymphoma and are not currently on chemotherapy or immunotherapy might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop chemotherapy or immunotherapy at least 2 weeks before starting the study. Some treatments, like certain systemic therapies for CTCL, are allowed up to 2 weeks before enrollment. It's best to discuss your specific medications with the study team to see if they are allowed.

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

Research has shown that ruxolitinib is generally well-tolerated by patients. In one study, about 42% of patients experienced side effects, but only a few were directly caused by ruxolitinib. Most side effects were manageable and did not require stopping the treatment. Ruxolitinib has also been used successfully for other conditions, which supports its safety.

For pembrolizumab, studies have found it to be well-tolerated. The FDA has already approved it for other conditions, indicating a known safety profile. Most side effects are mild to moderate, such as tiredness and nausea. Serious side effects are less common but can occur.

In summary, both ruxolitinib and pembrolizumab have been studied and found to be relatively safe, with most side effects being manageable. ^{1 2 3 4}

Why are researchers excited about this trial's treatments?

Ruxolitinib is unique because it targets the JAK-STAT pathway, which is a different mechanism from standard chemotherapy or radiation treatments commonly used for lymphoma. Most treatments for lymphoma attack rapidly dividing cells indiscriminately, but Ruxolitinib specifically inhibits certain proteins involved in cell growth and survival, potentially leading to fewer side effects. Researchers are excited about combining Ruxolitinib with Pembrolizumab, an immunotherapy drug that helps the immune system recognize and attack cancer cells, offering a one-two punch that could improve treatment outcomes and extend remission periods for patients.

What evidence suggests that ruxolitinib added to pembrolizumab could be an effective treatment for lymphoma?

Research has shown that ruxolitinib, which participants in this trial may receive, can help treat certain types of lymphoma. One study controlled the disease in 54% of patients with Hodgkin lymphoma, with effects lasting about 5.6 months. Another study found that 41.9% of patients responded well to ruxolitinib, compared to just 0.7% who took a placebo. Pembrolizumab, another treatment option in this trial, is often used for different cancers and helps the immune system find and attack cancer cells more effectively. Combining ruxolitinib with pembrolizumab might improve treatment results, offering a new option for people with Hodgkin and non-Hodgkin lymphomas that have returned or are difficult to treat. ^{2 3 4 5 6}

Who Is on the Research Team?

Seda Tolu, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with various types of lymphoma, including Mixed-Cell, Peripheral T-Cell, Hodgkin's, Cutaneous T-Cell, Non-Hodgkin's and Large B-Cell Lymphoma. Participants should have relapsed or refractory conditions after previous treatments.

Inclusion Criteria

I am 18 years old or older.

My cancer can be measured by tests.

I haven't had chemotherapy or immunotherapy in the last 2 weeks and have recovered from any side effects.

Exclusion Criteria

I do not have active tuberculosis.

Severe hypersensitivity to pembrolizumab and/or ruxolitinib

I cannot swallow or take medications orally.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib 20mg PO twice daily in combination with pembrolizumab

12 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• Ruxolitinib

Trial Overview

The study is testing the combination of two drugs: Ruxolitinib and Pembrolizumab to see if they're safe and effective when used together in patients with different kinds of lymphomas that haven't responded well to other treatments.

How Is the Trial Designed?

Group I: Ruxolitinib Experimental Treatment 2 Interventions

Ruxolitinib 20mg PO twice daily will be continued until 12 months, disease progression, or development of intolerable side effects (whichever occurs first).

Who Is Running the Clinical Trial?

Seda S. Tolu

Lead Sponsor

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6842512/

Ruxolitinib shows activity against Hodgkin lymphoma but not ...

The disease control rate for HL was 54% (7/13) with median response duration of 5.6 months. JAK2 amplification was present in six of nine patients tested (four ...

2.

lymphomahub.com

lymphomahub.com/medical-information/the-efficacy-and-safety-of-the-jak-12-inhibitor-ruxolitinib-in-tcl

The efficacy and safety of the JAK 1/2 inhibitor ruxolitinib in ...

The overall response rate (ORR) in 52 evaluable patients was 25% and the clinical benefit rate (CBR) was 35%, with a complete response (CR) rate ...

3.

chi.scholasticahq.com

chi.scholasticahq.com/article/87501-incorporation-of-ruxolitinib-in-the-management-of-refractory-relapsed-hodgkin-lymphoma-where-do-we-stand

Incorporation of Ruxolitinib in the Management of Refractory ...

The response rate was 54%, with one complete remission, one stable disease, and five partial remissions, with a median response duration of 5.6 ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1110557

A Double-Blind, Placebo-Controlled Trial of Ruxolitinib for ...

Results. The primary end point was reached in 41.9% of patients in the ruxolitinib group as compared with 0.7% in the placebo group (P<0.001) ...

5.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35489

Clinical outcomes of ruxolitinib treatment in 595 intermediate ...

Overall survival and event-free survival rates are significantly superior, whereas rate of ruxolitinib discontinuations is significantly ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5927969/

A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in ...

Overall, 40 adverse events were observed in 14/33 patients (42.4%). In six patients, the adverse events were related to the ruxolitinib therapy. In eight of ...