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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by 24 weeks
Awards & highlights
Study 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 belowSelect...
My LMS cannot be removed by surgery and has spread.
Select...
I finished any cancer treatments at least 3 weeks ago, and my side effects are mild.
Select...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 weeks
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 • NCT0196821376%
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%
Anxiety
8%
Neutrophil count decreased
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
1,937 Previous Clinical Trials
588,300 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
2,645 Previous Clinical Trials
4,130,979 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
35 Patients Enrolled for Leiomyosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within the required range.My LMS cannot be removed by surgery and has spread.I finished any cancer treatments at least 3 weeks ago, and my side effects are mild.I can take care of myself and perform daily activities.I finished my radiation therapy at least 2 weeks ago.I do not have any other cancer that needs treatment or could affect this trial.I am 18 years old or older.I have a weakened immune system due to conditions like HIV, Hepatitis B/C, or autoimmune diseases.You have had an allergic reaction to any ingredient in the study drug.I can provide tissue samples for study, either a block or 20 slides.My blood, kidney functions, and blood cell counts are within the required ranges.I have had a stem cell or organ transplant in the past.I have had 1 to 3 treatments for my LMS, or I declined the first standard treatment.I am not pregnant, willing to use birth control during and 6 months after the study, and will not breastfeed.I do not have any severe illnesses or recent major heart issues, and if I have brain metastases, they are stable without recent treatment changes.I have recovered from previous treatment side effects, except for hair loss or stable nerve pain.My cancer can be measured and has grown in previously treated areas.I have a stomach or intestine condition that affects how my body absorbs medication.I have never been treated with PARP inhibitors or PD-1/PD-L1 antibodies.I have lung inflammation not caused by an infection.I am not pregnant or breastfeeding.I am willing to have a biopsy if my doctor thinks it's safe.
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib in combination with Nivolumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for more people in this trial?
"Although this specific trial is no longer looking for participants, 817 other clinical trials are. This particular study was first posted on November 5th 2020 and updated last on September 6th 2022 according to the website clinicaltrials.gov"
Answered by AI
What are the approved uses for Rucaparib?
"Rucaparib is frequently used to help patients with malignant neoplasms, but it can also be given as treatment for other diseases such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
How many different facilities are coordinating this clinical trial?
"So far, 8 clinical trial sites are running this protocol, including Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge, Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, and Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale."
Answered by AI
How many patients are included in this clinical trial?
"As of September 6th, 2022, this study is no longer admitting patients. The trial was first posted on 11/5/2020. If you are interested in other clinical trials, there are 773 studies for Rucaparib and 44 leiomyosarcoma trials that are still recruiting participants."
Answered by AI
What is the official government stance on Rucaparib?
"While there is some clinical evidence supporting the safety of Rucaparib, it only received a 2 because Phase 2 trials lack data regarding efficacy."
Answered by AI
Can you please tell me what studies have been done using Rucaparib in the past?
"At present, there are 773 clinical trials underway for Rucaparib. 88 of those live studies are in Phase 3. While the majority of trials for Rucaparib are based in Columbus, Ohio, there are 42175 locations running studies for this treatment."
Answered by AI
What makes this clinical trial unique?
"Rucaparib has been under clinical study for a decade. The first official research project occurred in 2010 and was funded by Medarex. After the initial 127-person Phase 1 trial, Rucaparib received drug approval. Currently, there are 773 active trials involving this medication taking place in 2398 cities and 50 countries around the world."
Answered by AI
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