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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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 weeks

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

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

Primary study objectives

Best objective response rate

Secondary study objectives

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

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Neutrophil count decreased

Hypercholesterolaemia

Anxiety

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

General physical health deterioration

Incarcerated hernia

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: 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

Nivolumab

FDA approved

Rucaparib

FDA approved

0 / 9Eligibility criteria met