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Checkpoint Inhibitor
Rucaparib + Nivolumab for Biliary Tract Cancer
Phase 2
Waitlist Available
Led By Vaibhav Sahai, MBBS, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Available archived tissue
ECOG performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years post treatment discontinuation
Awards & highlights
Study Summary
This trial is testing if a combination of drugs can improve survival in biliary tract cancer patients.
Who is the study for?
This trial is for adults with advanced biliary tract cancer who've had platinum-based chemotherapy but can't have surgery or other curative treatments. They must be in good physical condition, not have certain other cancers or serious medical issues, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests if rucaparib combined with nivolumab improves survival for patients after first-line platinum chemotherapy. It's for those whose disease hasn't worsened during initial treatment and who meet specific health criteria.See study design
What are the potential side effects?
Rucaparib may cause nausea, fatigue, blood count changes, and liver enzyme alterations. Nivolumab can lead to immune-related side effects like inflammation of organs, skin rash, hormone gland problems, and infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tissue samples from previous procedures stored.
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I am fully active or can carry out light work.
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I've had platinum-based chemo for 4-6 months for advanced bile duct cancer without it getting worse.
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I am 18 years old or older.
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My liver function is moderately to mildly impaired.
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I can safely undergo CT or MRI scans with contrast.
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My cancer is a type of biliary tract cancer that cannot be removed or cured with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years post treatment start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years post treatment start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients alive and without radiological or clinical progression at 4 months
Secondary outcome measures
Overall survival (OS) time as measured from start of 1st line platinum therapy
Overall survival (OS) time as measured from treatment start
Progression free survival (PFS) time as measured from start of 1st line platinum therapy
+2 moreSide 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 and NivolumabExperimental Treatment2 Interventions
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Rucaparib
2016
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,229 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,948 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
672,161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease that affects my organs or requires immunosuppressive therapy.I finished chemotherapy over 6 months ago before starting platinum-based treatment for advanced disease.I have another active cancer besides non-melanoma skin cancer or cervical carcinoma in situ.I do not have any current, uncontrolled infections.I have tissue samples from previous procedures stored.I am fully active or can carry out light work.I have not taken steroids or immunosuppressants in the last 14 days.I haven't taken steroids or immunosuppressants in the last 14 days.I've had platinum-based chemo for 4-6 months for advanced bile duct cancer without it getting worse.I had cancer treatment over 4 weeks ago and have mostly recovered.I have a tumor that can be measured and hasn't been treated with radiation or targeted liver therapy.I am 18 years old or older.My liver function is moderately to mildly impaired.I can understand and am willing to sign the consent form.I have not been treated with anti PD1/PDL1 antibodies or PARP inhibitors for my cancer.I can safely undergo CT or MRI scans with contrast.My organs are functioning well, as tested within the last 2 weeks.I have not had major surgery in the last 4 weeks.My cancer is a type of biliary tract cancer that cannot be removed or cured with surgery.I have not received a live vaccine in the last 30 days.I have had a solid organ transplant or brain metastasis.
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib and Nivolumab
Awards:
This trial has 1 awards, including:- 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.
Are there still openings available for individuals to participate in this medical experiment?
"Affirmative. Data on clinicaltrials.gov verifies that this investigation is still actively seeking participants, having been first published on March 28th 2019 and last edited February 8th 2022. The trial requires 35 volunteers to be recruited across 3 centres."
Answered by AI
To what conditions is Rucaparib typically prescribed?
"Rucaparib is an effective therapeutic option for treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Is this a pioneering analysis or have similar studies been conducted?
"Since its first investigation in 2012, sponsored by Ono Pharmaceutical Co. Ltd., Rucaparib has become a highly studied drug with 743 active trials located within 2389 cities and 49 countries. After the initial 659-participant study that year, Phase 1 & 2 approval was granted to this medication."
Answered by AI
What other research endeavors have employed Rucaparib for evaluation?
"Currently, there are 743 clinical trials assessing the efficacy of Rucaparib. Of these active studies, 87 are in Phase 3. Though much of this research is centred around Columbus Ohio, over 40 thousand sites across the world have been enlisted to evaluate this new drug."
Answered by AI
What is the upper limit of participants enrolled in this clinical experiment?
"To ensure this clinical study is adequately powered, it requires the recruitment of 35 individuals who satisfy its eligibility requirements. Potential participants can find a trial location at Vanderbilt University Medical Center in Nashville or Dana-Farber Cancer Institute in Boston."
Answered by AI
Could you elucidate the potential perils of Rucaparib?
"Previous clinical data has demonstrated a degree of safety, thusly it was given an evaluation score of 2. Nonetheless, no efficacy data is available yet as this research initiative is still in Phase 2."
Answered by AI
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