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Checkpoint Inhibitor

Rucaparib + Nivolumab for Leiomyosarcoma

Phase 2
Waitlist Available
Led By Sujana Movva, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have a histologically confirmed unresectable/metastatic LMS
Patients who were treated with chemotherapy or any investigational therapies or other anti-cancer agent, if eligible, must have been completed at least 3 weeks or at least 5 half-lives (whichever is longer, but no less than 3 weeks) before the study drug administration. All AEs must be ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline. Patients who were treated with estrogen modulating therapies (aromatase inhibitors, tamoxifen, GnRH agonists etc.) must have been treated at least 2 weeks prior to study drug administration.
Must not have
Presence of any other concurrent malignancy requiring active therapy or thought to potentially interfere with the safe conduct or assessment of outcomes on this trial
Prior allogeneic stem cell transplantation or organ transplantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by 24 weeks
Awards & highlights

Summary

This trial is testing whether combining two drugs, rucaparib and nivolumab, may be effective in treating leiomyosarcoma (LMS), a type of cancer.

Who is the study for?
Adults (18+) with advanced or metastatic Leiomyosarcoma who have had 1-3 prior systemic therapies can join this trial. They must not have used PARP inhibitors or PD-1/PD-L1 antibodies before, and should be recovered from previous treatments' side effects. Participants need functioning major organs, measurable disease, and no active infections or significant heart issues. Women of childbearing potential must test negative for pregnancy and agree to contraception.Check my eligibility
What is being tested?
The study is testing the combination of Rucaparib (a drug that targets cancer cells) and Nivolumab (an immunotherapy) in patients with Leiomyosarcoma to see if it's more effective than standard chemotherapy. Patients will receive both drugs as part of their treatment regimen.See study design
What are the potential side effects?
Rucaparib may cause nausea, fatigue, blood count changes, while Nivolumab might lead to immune-related side effects like inflammation in various organs including lungs (pneumonitis), liver problems, skin rash, endocrine disorders such as thyroid dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My LMS cannot be removed by surgery and has spread.
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I finished any cancer treatments at least 3 weeks ago, and my side effects are mild.
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I can take care of myself and perform daily activities.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any other cancer that needs treatment or could affect this trial.
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I have had a stem cell or organ transplant in the past.
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I have never been treated with PARP inhibitors or PD-1/PD-L1 antibodies.
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I have lung inflammation not caused by an infection.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best objective response rate
Secondary outcome measures
Progression free survival (PFS)

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213
76%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Pruritus
15%
Rash
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Anxiety
8%
Hypercholesterolaemia
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rucaparib in combination with NivolumabExperimental Treatment2 Interventions
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks. Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,731 Total Patients Enrolled
7 Trials studying Leiomyosarcoma
263 Patients Enrolled for Leiomyosarcoma
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,651 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,729 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
35 Patients Enrolled for Leiomyosarcoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04624178 — Phase 2
Leiomyosarcoma Research Study Groups: Rucaparib in combination with Nivolumab
Leiomyosarcoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04624178 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624178 — Phase 2
~1 spots leftby Nov 2024
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