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ATRA + Cemiplimab for Sarcoma

Phase 2

Waitlist Available

Led By Gabriel Tinoco, MD

Research Sponsored by Gabriel Tinoco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Patients must have received standard of care chemotherapy. No limits to prior lines of therapy.

Must not have

Prior allogeneic stem cell or solid organ transplantation

History of specific pulmonary conditions or evidence of active pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of a combination of all-trans retinoic acid (ATRA) and Cemiplimab in patients with advanced leiomyosarcoma who have not responded to

Who is the study for?

This trial is for patients with advanced leiomyosarcoma, a type of sarcoma, who have not responded to standard treatments. Participants must have metastatic or locally advanced disease that cannot be surgically removed.

What is being tested?

The study tests the combination of all-trans retinoic acid (ATRA) taken orally and Cemiplimab given intravenously in cycles. The effectiveness will be measured using imaging techniques like CT and MRI scans following a specific study design called BOP2.

What are the potential side effects?

Possible side effects include skin reactions, fatigue, immune-related issues such as inflammation in organs due to Cemiplimab, and headaches or bone pain from ATRA. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have undergone standard chemotherapy for my condition.

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I am able to care for myself and perform daily activities.

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My blood, kidney, liver, and coagulation tests are within normal ranges.

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I am a woman who can have children and have a recent negative pregnancy test.

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My cancer, Leiomyosarcoma, cannot be removed by surgery and has spread.

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I can swallow and keep down pills.

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I have chronic hepatitis B but it's under control with treatment.

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I had hepatitis C but have been treated and cured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a previous organ or stem cell transplant.

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I have a history of lung conditions or currently have lung inflammation.

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I have had major surgery recently or expect to need one during the study.

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I am currently on medication for hepatitis B.

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I have not taken more than 10 mg of steroids daily in the last 2 weeks.

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My liver condition is severe, classified as Child-Pugh B or worse.

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I experienced severe side effects from previous immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Overall survival (OS)

Progression-free survival (PFS)

Other study objectives

Effect of ATRA on myeloid-derived suppressor cells (MDSCs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (all-trans retinoic acid [ATRA] and cemiplimab)Experimental Treatment4 Interventions

Patients recieve ATRA at a starting dose of 150 mg/m2/day for 3 days orally prior to each cycle of Cemiplimab 350 mg IV q3 weeks for three cycles and then Cemiplimab monotherapy until the progress of disease or unacceptable toxicities develops. Peripheral blood samples will be collected. Patients will undergo physical examination and imaging scans at baseline and then approximately every 6 weeks (2 cycles) for the first year of treatment and every 12 weeks thereafter

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

all-trans retinoic acid

2007

Completed Phase 3

~280

Cemiplimab

2015

Completed Phase 3

~1470