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PARP Inhibitor
PARP Inhibitor + CTLA-4 Blockade for Ovarian Cancer
Phase 1 & 2
Waitlist Available
Led By Sarah F Adams, MD
Research Sponsored by New Mexico Cancer Care Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma for which standard curative measures do not exist
Patients with platinum-sensitive or platinum-resistant disease are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat ovarian cancer that is caused by a BRCA mutation. The drugs are a PARP inhibitor and a T cell checkpoint inhibitor. The trial is testing to see if this combination is safe and effective.
Who is the study for?
This trial is for women with recurrent ovarian cancer linked to BRCA mutations, who've had platinum-based chemo. They must have good organ function and a performance status of 0-2, indicating they can carry out daily activities with varying degrees of assistance. Participants need measurable disease and cannot be on other cancer treatments or have autoimmune diseases, uncontrolled illnesses, or known allergies to the drugs being tested.Check my eligibility
What is being tested?
The study tests Olaparib (a PARP inhibitor) combined with Tremelimumab (an anti-CTLA-4 antibody) in treating BRCA mutation-associated ovarian cancer. It aims to see if this combo improves survival rates by targeting DNA repair mechanisms in cancer cells while also stimulating the immune system.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood count changes from Olaparib; Tremelimumab may cause immune-related issues like inflammation in organs or skin problems. Both drugs could potentially lead to allergic reactions based on individual sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian, fallopian tube, or peritoneal cancer has returned and cannot be cured with standard treatments.
Select...
My condition responds to or resists platinum-based treatment.
Select...
I have a confirmed genetic mutation in either the BRCA1 or BRCA2 gene.
Select...
I have had platinum-based chemotherapy before for my cancer.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 2: Objective response rate (ORR)
Secondary outcome measures
Phase 2: Progression free survival (PFS)
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Olaparib and TremelimumabExperimental Treatment2 Interventions
Each cycle is 28 days:
Olaparib at 300 mg, orally, twice daily + Tremelimumab at 10 mg/kg, intravenously, every 4 weeks for the first 6 doses, then every 12 weeks until disease progression or unacceptable toxicity.
If 1 of the first 3 patients experiences a regimen-limiting toxicity (RLT), 3 more patients will be treated with 10 mg/kg Tremelimumab in Phase 1. If 2 or more of 6 patients experience RLT, then 6 mg/kg Tremelimumab will be tested
If at 6 mg/kg, 1 or more of 3 patients experience RLT, 3 patients will be treated at 3 mg/kg Tremelimumab
If at 3 mg/kg, 1 or more patients experience RLT, the study will be discontinued for safety purposes
In Phase 2, patients will receive doses of Olaparib and Tremelimumab determined in the Phase 1 portion as described above, based on tolerability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
New Mexico Cancer Care AllianceLead Sponsor
70 Previous Clinical Trials
52,417 Total Patients Enrolled
8 Trials studying Ovarian Cancer
225 Patients Enrolled for Ovarian Cancer
Sarah F Adams, MDPrincipal InvestigatorUniversity of New Mexico Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped my cancer hormone therapy at least a week ago.You have HIV or other immune system problems.I stopped all cancer treatments at least 3 weeks ago.I stopped any radiation therapy at least 4 weeks ago.I do not have an autoimmune disorder requiring steroids or immunosuppressants, except for vitiligo.I regularly take drugs that suppress my immune system.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My organs and bone marrow are functioning well.My heart's electrical activity (QTc) is prolonged, or I have a family history of long QT syndrome.My ovarian, fallopian tube, or peritoneal cancer has returned and cannot be cured with standard treatments.My condition responds to or resists platinum-based treatment.I am not taking strong CYP3A4 inhibitor medications.Patients must have a disease that can be measured using the World Health Organization's criteria.I have recovered from recent cancer treatments.I may have had any number of previous treatments.I do not have any infections that need antibiotics.I have lasting side effects from cancer treatment, but not hair loss.I have a confirmed genetic mutation in either the BRCA1 or BRCA2 gene.I have been treated with anti-CTLA-4 antibody therapy before.I have had platinum-based chemotherapy before for my cancer.I can take care of myself but might not be able to do heavy physical work.You have had allergic reactions to drugs similar to olaparib or tremelimumab in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib and Tremelimumab
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.
How many participants are receiving treatment as part of this medical experiment?
"This specific clinical trial is not currently accepting new participants. It was released on February 23rd 2016 and last updated October 4th 2022. On the other hand, 738 trials are actively seeking patients with peritoneal neoplasms while 272 studies require Olaparib volunteers."
Answered by AI
Are there numerous locations in the state that are participating in this research?
"Potential participants have the option to join this medical study at Moffitt Cancer Center in Tampa, University of New mexico Comprehensive Cancer Center in Columbus, The Ohio State University in Charlottesville and other 5 sites."
Answered by AI
Has Olaparib been subject to any prior investigations?
"Currently, 272 trials are underway for Olaparib worldwide. Of these active investigations, 39 of them have advanced to the third stage in clinical development. Most studies relating to olaparib occur within Phoenix, AZ however there is a total of 11925 locations where research is being conducted."
Answered by AI
Is admission to this trial open for participants at the moment?
"The clinicaltrials.gov listing shows that this trial is no longer accepting patients, having been initially listed on February 23rd 2016 and last edited October 4th 2022. Nevertheless, there are presently 1,010 other trials seeking participants."
Answered by AI
In what conditions is Olaparib commonly prescribed?
"Olaparib is commonly administered to patients with advance directives, but has also been known to benefit those afflicted by malignant neoplasm of ovary, primary peritoneal cancer, and somatic hallucinations."
Answered by AI
Does this trial represent a new approach to the particular condition?
"Research into Olaparib began in 2005 with a trial sponsored by AstraZeneca. After the successful completion of this Phase 1 study, which included 98 participants, approval was granted for further research and development. To date there are 272 olaparib studies being conducted across 1531 cities and 62 nations around the world."
Answered by AI
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