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Monoclonal Antibodies
Triple Therapy for Ovarian Cancer
Phase 2
Waitlist Available
Led By Emese Zsiros
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying olaparib, durvalumab, and tremelimumab to treat patients with ovarian, fallopian tube, or primary peritoneal cancer.
Who is the study for?
This trial is for patients with recurrent or resistant ovarian, fallopian tube, or primary peritoneal cancer who have a BRCA1/2 mutation. It's open to those whose cancer didn't respond well to platinum-based chemotherapy and show genetic features of HR deficiency. Patients must not have responded to initial treatments or had their disease return after treatment.Check my eligibility
What is being tested?
The study tests the combination of olaparib (a drug blocking enzymes for cell growth) with durvalumab and tremelimumab (monoclonal antibodies that may stimulate the immune system). The goal is to determine the best dose and effectiveness in treating these specific cancers.See study design
What are the potential side effects?
Possible side effects include reactions related to immune stimulation such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues, skin rash, hormonal imbalances and potential increase in infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3 Month Progression Free Survival (PFS) in the All Eligible Patients by Group/Arm
6 Month Progression Free Survival (PFS) in the Platinum Sensitive Group (Phase II)
Mutagenicity Tests
Secondary outcome measures
Anti-tumor Immune Response of the Treatment Combination Assessed in Tumor Biopsy
Overall Survival (OS)
Other outcome measures
Auto-antibody analysis of pre- and post- treatment tumor biopsies and peripheral blood samples
Potential resistance mechanism assessed by sequencing studies (e.g. for homologous recombination deficiency), gene expression studies and analysis for secondary genetic and epigenetic event
T-cell responses
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: Treatment (olaparib, tremelimumab, durvalumab)Experimental Treatment4 Interventions
Patients receive olaparib PO BID, and tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with olaparib continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Treatment with tremelimumab repeats every 4 weeks for up to 4 courses and treatment with durvalumab repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Olaparib
FDA approved
Tremelimumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,818 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,862 Total Patients Enrolled
2 Trials studying BRCA2 Mutation
32 Patients Enrolled for BRCA2 Mutation
Emese ZsirosPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ovarian cancer did not improve with initial treatment.My cancer responded to platinum-based treatment and I've been off this treatment for over 6 months.My ovarian, fallopian tube, or peritoneal cancer responds to platinum treatment or is resistant, and I have a genetic test report.My ovarian cancer has come back after initially responding to treatment.My ovarian cancer is still present after initial treatment.My cancer returned or got worse within 6 months after platinum chemotherapy.I have a harmful BRCA1 or BRCA2 gene mutation.My cancer has a BRCA1 or BRCA2 mutation.I have a genetic mutation affecting DNA repair.My cancer shows a high level of genetic changes linked to HR deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib, tremelimumab, durvalumab)
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 this study still looking for participants?
"The clinical trial hosted on clinicaltrials.gov is no longer recruiting patients for participation. Although this study has completed, there are still 3928 other trials that are ongoing and actively enrolling individuals."
Answered by AI
What have researchers found in terms of the potential risks of Olaparib?
"While there is some evidence of its safety, olaparib only received a 2 because there is no data currently supporting efficacy."
Answered by AI
To your knowledge, are there any other similar studies currently being conducted?
"Olaparib has undergone 502 clinical trials since the first one in 2005. The initial study, which was completed in Phase 1 and sponsored by AstraZeneca, only involved 98 patients. However, over the past 16 years 744 trials have been completed for Olaparib across 1845 cities and 65 countries."
Answered by AI
What are the goals of this clinical trial?
"According to the trial sponsor's reporting, the primary outcome-- which will be observed over a 6 month period-- is the incidence of dose-limiting toxicities (DLTs). This study will also assess secondary outcomes like overall survival and anti-tumor immune response."
Answered by AI
How many individuals are included in this clinical research project?
"This trial has concluded its recruitment process. The study was first announced on 6/29/2017 and received its last update on 9/8/2022. However, there are presently 3426 trials actively admitting participants with relapse and 502 studies for Olaparib that are still looking for patients."
Answered by AI
How is Olaparib utilized in medical treatment?
"Olaparib has potential as a disease-modifying treatment for conditions like pharmacotherapy, primary peritoneal cancer, and advance directives."
Answered by AI
Are there any other existing trials that use Olaparib as a treatment?
"At the moment, there are 502 clinical trials underway that are researching Olaparib. Out of those, 74 are in Phase 3. Although a majority of the trials for Olaparib are based in Houston, Texas, there are 20095 locations around the world running studies for this treatment."
Answered by AI
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