98 Participants Needed

Retifanlimab + Chemotherapy for Soft Tissue Sarcoma

Recruiting at 1 trial location
SP
WD
ER
Sandra D'Angelo, MD profile photo
Overseen BySandra D'Angelo, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently using immunosuppressive medication, except for certain types like low-dose steroids or specific premedications.

Is the combination of Retifanlimab, Gemcitabine, and Docetaxel safe for humans?

The combination of Gemcitabine and Docetaxel has been used in patients with soft tissue sarcoma, and while it shows some activity, it can cause expected chemotherapy-related side effects. These side effects were not severe enough to stop treatment in the studies reviewed.12345

What makes the drug combination of Retifanlimab, Docetaxel, and Gemcitabine unique for treating soft tissue sarcoma?

The combination of Retifanlimab with Docetaxel and Gemcitabine is unique because Retifanlimab is an immune checkpoint inhibitor that may enhance the body's immune response against cancer cells, potentially offering a novel mechanism of action compared to traditional chemotherapy alone, which primarily targets cancer cells directly.13567

What data supports the effectiveness of the drug combination Retifanlimab + Chemotherapy for Soft Tissue Sarcoma?

Research shows that the combination of gemcitabine and docetaxel, which are part of the chemotherapy regimen, is effective for treating advanced soft tissue sarcoma. This combination has shown activity in patients with metastatic sarcomas, suggesting it could be beneficial in this context.13568

Who Is on the Research Team?

ER

Evan Rosenbaum, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with advanced soft tissue sarcoma that can't be surgically removed may join this trial. They should have no prior systemic therapy, controlled hepatitis if present, and good organ function. Pregnant or breastfeeding women, those planning to conceive soon, and individuals with uncontrolled HIV or severe allergies to monoclonal antibodies cannot participate.

Inclusion Criteria

I have not had any systemic therapy before.
I have chronic HBV or HCV but it's under control.
Negative serum pregnancy test in women of childbearing potential
See 9 more

Exclusion Criteria

I am currently on medication for an infection.
I haven't had symptoms of autoimmune disease in the last 2 years, except for conditions treated with replacement therapies like insulin.
I received initial cancer treatment over a year ago.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine and docetaxel for 6 cycles, with Retifanlimab added from cycle 2, continuing until unacceptable toxicity, disease progression, or completion of 35 cycles

105 weeks
Visits every 3 weeks +/- 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • Gemcitabine
  • Retifanlimab
Trial Overview The trial tests Retifanlimab combined with chemotherapy drugs Gemcitabine and Docetaxel in patients with advanced soft tissue sarcoma. Researchers believe Retifanlimab might enhance the immune system's response when used alongside these chemotherapies.
How Is the Trial Designed?
10Treatment groups
Experimental Treatment
Group I: Vascular SarcomaExperimental Treatment3 Interventions
Group II: Undifferentiated Pleomorphic Sarcoma/MyxofibrosarcomaExperimental Treatment3 Interventions
Group III: Phase I: Safety Run-In / Dose Level 0Experimental Treatment3 Interventions
Group IV: Phase I: Dose De-escalation Level 1Experimental Treatment3 Interventions
Group V: Phase I: Dose De-escalation Level -2Experimental Treatment3 Interventions
Group VI: Phase I: Dose De-escalation Level -1Experimental Treatment3 Interventions
Group VII: Other Soft tissue sarcoma/STSExperimental Treatment3 Interventions
Group VIII: Liposarcoma/LPSExperimental Treatment3 Interventions
Group IX: Leiomyosarcoma/LMSExperimental Treatment3 Interventions
Group X: Advanced sarcoma who have progressed on prior treatmentExperimental Treatment1 Intervention

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

The combination of gemcitabine and docetaxel has shown effectiveness in treating metastatic sarcomas, particularly in leiomyosarcoma and undifferentiated high-grade pleomorphic sarcoma, expanding treatment options for oncologists.
There is evidence suggesting that the combination may work synergistically, especially since docetaxel alone has a low response rate, indicating that using both drugs together could enhance treatment outcomes.
Gemcitabine and docetaxel in metastatic sarcoma: past, present, and future.Maki, RG.[2022]
In a study of 10 pediatric patients with relapsed or refractory sarcomas, the combination of gemcitabine and docetaxel showed significant antitumor activity, with 50% of patients achieving a complete or partial response.
The treatment was well-tolerated, with only mild toxicities reported, and allowed for a median duration of response of 10 months, indicating a good quality of life for the patients during therapy.
Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel.Mora, J., Cruz, CO., Parareda, A., et al.[2022]
In a review of 21 patients with synovial sarcoma treated with gemcitabine/docetaxel chemotherapy, the treatment showed a low response rate of only 5% and a median progression-free survival of just 2 months, indicating limited efficacy.
Despite the expected toxicities associated with this chemotherapy combination, treatment was tolerated without discontinuation due to toxicity, but the authors recommend that this regimen should not be used outside of clinical trials for this patient group.
Poor treatment outcomes with palliative gemcitabine and docetaxel chemotherapy in advanced and metastatic synovial sarcoma.Pender, A., Davis, EJ., Chauhan, D., et al.[2022]

Citations

Gemcitabine Plus Anlotinib Is Effective and Safe Compared to Gemcitabine Plus Docetaxel in Advanced Soft Tissue Sarcoma. [2022]
Phase IB study of the combination of docetaxel, gemcitabine, and bevacizumab in patients with advanced or recurrent soft tissue sarcoma: the Axtell regimen. [2023]
Gemcitabine and Docetaxel Combination for Advanced Soft Tissue Sarcoma: A Nationwide Retrospective Study. [2022]
Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. [2022]
Gemcitabine and docetaxel in metastatic sarcoma: past, present, and future. [2022]
Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel. [2022]
Poor treatment outcomes with palliative gemcitabine and docetaxel chemotherapy in advanced and metastatic synovial sarcoma. [2022]
Phase II Trial of Gemcitabine and Docetaxel with Bevacizumab in Soft Tissue Sarcoma. [2020]
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