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A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma | Clinical Trials | Clareo Health

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A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma

Phase II Study of Rucaparib and Nivolumab in Patients With Leiomyosarcoma

NCT04624178•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to find out whether combining the study drugs rucaparib and nivolumab may be an effective treatment for advanced and/or metastatic LMS, and whether the study treatment works as well as the standard chemotherapy for this type of cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female age ≥ 18 years at the time of informed consent
•Be willing and able to provide written informed consent/assent for the trial
•Be willing to comply with treatment protocol
•Subjects must have a histologically confirmed unresectable/metastatic LMS
•Availability of archival tissue for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable
•Adequate performance status: ECOG 0 - 2
•Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their LMS. Patients who decline the standard of care first-line systemic therapy will be eligible for this trial. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.
•Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
•Adequate organ function determined within 14 days of treatment initiation, defined as per Hematological
•Absolute neutrophil count (ANC) ≥1.5 K/mcL
+14 more criteria

Exclusion Criteria

•Uncontrolled intercurrent illness including current active or chronic infection requiring systemic therapy or the following cardiac criteria:
•* Symptomatic congestive heart failure (NYHA classification III or IV) within 6 months
•* Acute myocardial infarction ≤6 months prior to Day 1
•* Grade ≥2 ventricular arrhythmia ≤6 months prior to Day 1
•* History of cerebrovascular accident within 6 months before first dose of study drugs
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
•Evidence of clinically significant immunosuppression such as the following:
•* Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
•* Concurrent opportunistic infection
•* Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for steroid use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator. The dose of steroid allowed in this setting is also at the discretion of the principal investigator. (Use of inhaled or topical steroids is permitted.)
+16 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

November 5, 2020

Primary Completion Date

November 16, 2026

Completion Date

November 16, 2026

Last Updated

November 20, 2025

Enrollment

ACTUAL participants

Conditions

Leiomyosarcoma

Interventions

Rucaparib

DRUG

Nivolumab

DRUG

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

NCT06088290

Leiomyosarcoma

View study

RECRUITING

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

NCT07432932

SarcomaSarcoma, Leiomyo-, Adult+10 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma

Inclusion Criteria

Exclusion Criteria

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Beliefs, Attitudes, and Response to Genetic Testing in SarcomaPatients

Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour

Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy