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PARP Inhibitor
Tremelimumab + Olaparib for Recurrent Ovarian Cancer
Phase 2
Waitlist Available
Led By Sarah F Adams
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight > 30 kg
Patients who demonstrated disease progression while on a PARP inhibitor are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the median follow-up is 22 months. since the study was stopped early, the follow-up time frame for objective response was significantly reduced.
Awards & highlights
Study Summary
This trial is testing olaparib, a PARP inhibitor, with and without tremelimumab, an immunotherapy drug, to see if they are effective in treating patients with ovarian, fallopian tube, or peritoneal cancer that has returned.
Who is the study for?
This trial is for adults with recurrent high-grade ovarian, fallopian tube, or peritoneal cancer that's sensitive to platinum-based therapy. Participants must have a BRCA1/2 mutation and measurable disease. They should not have progressed on PARP inhibitors if used before and can't be pregnant. People with certain heart conditions, active infections, autoimmune diseases requiring recent treatment, or those on immunosuppressants are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining Olaparib (a PARP inhibitor) with Tremelimumab (an immunotherapy drug) versus using Olaparib alone in patients whose cancer has returned. It aims to see if this combination helps the immune system better attack cancer cells and prevents them from repairing themselves.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to other drugs like Olaparib or Tremelimumab, symptoms from previous cancer treatments except hair loss and skin discoloration, increased risk of infection due to immune suppression by medications being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body weight is over 30 kg.
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My condition worsened while I was on a PARP inhibitor treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I responded well to my last platinum-based cancer treatment without it getting worse.
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My thyroid function is normal, with no symptoms of dysfunction.
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I've had chemotherapy after my first-line maintenance therapy with a PARP inhibitor.
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My cancer responds to platinum-based treatment and is a high-grade type in the ovary, peritoneum, or fallopian tube.
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I am 18 years old or older.
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My first cancer treatment included platinum-based drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the median follow-up is 22 months. since the study was stopped early, the follow-up time frame for objective response was significantly reduced.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the median follow-up is 22 months. since the study was stopped early, the follow-up time frame for objective response was significantly reduced.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicity (DLT) (Safety Lead-In)
Progression Free Survival (PFS)
Secondary outcome measures
Number of Participants Died
Number of Participants With Adverse Event of Grade 3 or Higher
Objective Response (RECIST 1.1)
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (olaparib, tremelimumab)Experimental Treatment4 Interventions
Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Group II: Arm I (olaparib)Active Control4 Interventions
Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Tremelimumab
2017
Completed Phase 2
~3380
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
232 Previous Clinical Trials
101,128 Total Patients Enrolled
2 Trials studying Fallopian Tube Carcinoma
621 Patients Enrolled for Fallopian Tube Carcinoma
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,310 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
Sarah F AdamsPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe nerve pain or damage.My body weight is over 30 kg.Your white blood cell count is at least 1,500 per microliter.I have an autoimmune disease treated with medication in the last 2 years.I have used a PARP inhibitor for my BRCA1 or BRCA2 mutation.Your hemoglobin level should be at least 10 grams per deciliter within 14 days before joining the study.I do not have any serious ongoing illnesses that could affect my participation in the study.Your AST and ALT levels are not more than three times the normal limit at the time of enrollment.My condition worsened while I was on a PARP inhibitor treatment.I can take care of myself and am up and about more than half of my waking hours.Your bilirubin levels must be within a certain range, as determined by the hospital's normal limit.Your kidney function, as measured by creatinine levels, must be within a certain range.I have received anti-CTLA-4 antibody therapy before.I haven't taken immunosuppressive drugs in the last 14 days.I do not show signs of blood disorders like MDS or AML.I responded well to my last platinum-based cancer treatment without it getting worse.I have a harmful BRCA1 or BRCA2 mutation.You have had allergic reactions to drugs similar to olaparib or tremelimumab.Patients must have a measurable disease according to RECIST 1.1 guidelines.I have not had a blood transfusion in the last 28 days.I have not received any live vaccines in the last 30 days.I have had multiple platinum-based treatments for cancer recurrence.I have not had any type of organ or tissue transplant from a donor.You are not pregnant or in menopause.You are expected to live for at least 12 weeks.Your platelet count is at least 100,000 per microliter within 14 days before joining the trial.My brain scans show no worsening after treatment for brain metastases.My thyroid function is normal, with no symptoms of dysfunction.I've had chemotherapy after my first-line maintenance therapy with a PARP inhibitor.My cancer responds to platinum-based treatment and is a high-grade type in the ovary, peritoneum, or fallopian tube.I regularly take drugs that weaken my immune system for cancer or other illnesses.I am not currently taking strong CYP3A4 inhibitors or inducers.I do not have a bowel obstruction.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My ECG shows a QT interval over 470 msec, or I have a family history of long QT syndrome.I have side effects from past cancer treatments, but not hair loss or skin changes.I stopped any radiation therapy at least 28 days before joining.I stopped my cancer hormone therapy at least 28 days ago.I have not had major surgery in the last 28 days.My condition did not worsen for over 6 months after my last platinum-based treatment.I stopped any cancer treatments at least 28 days before joining.I am 18 years old or older.I have had one non-platinum treatment for my recurring cancer.My first cancer treatment included platinum-based drugs.I have previously received bevacizumab therapy.I understand the study drugs may harm a pregnancy.I do not have significant liver disease like hepatitis or cirrhosis.I do not have an active infection needing antibiotics, except for simple UTIs.I can swallow pills and don't have stomach issues affecting medicine absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (olaparib)
- Group 2: Arm II (olaparib, 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.
Is this the inaugural investigation into this research topic?
"Presently, AstraZeneca's Olaparib drug has 272 active studies taking place in 1531 cities over 62 countries. The initial testing period for this medication began back in 2005 and involved 98 patients. Over the past 16 years, 127 additional trials have been conducted to further evaluate its safety and effectiveness."
Answered by AI
What are the geographical points of deployment for this clinical experiment?
"20 sites across the US are administering this trial, including Hartford, Aurora and Orange. Participants should choose a location most convenient for them to reduce travel time if they join in."
Answered by AI
What is the aggregate amount of participants engaged in this research?
"This clinical trial is no longer accepting patient enrolment. It was first listed on November 10th 2019 with the last update occurring on August 11th 2022. Currently, there are 4243 studies open for patients suffering from fallopian tube issues and 272 recruiting individuals to try Olaparib medication."
Answered by AI
Has Olaparib been given regulatory permission by the Food and Drug Administration?
"The safety of Olaparib was assessed to be a 2 since this is a Phase 2 trial, which indicates that there are some studies suggesting the drug's security but none validating its efficacy."
Answered by AI
What medical maladies can be addressed through the use of Olaparib?
"Olaparib is a tenable solution for treating advance directives, malignant neoplasms of the ovary, and primary peritoneal cancer."
Answered by AI
Can you please enumerate any other investigations that have explored the use of Olaparib?
"Currently, 39 Phase 3 studies are underway investigating Olaparib with 272 trials live worldwide. An abundance of trial sites in Rochester, Minnesota offer this medication; however, it is available at 11925 different locations globally."
Answered by AI
Is enrollment open for this scientific experiment?
"As indicated on clinicaltrials.gov, the recruitment phase for this trial has been concluded. It was first posted on October 11th 2019 and last updated November 8th 2022; however, there are 4515 similar trials presently searching for participants to take part in their studies at present."
Answered by AI
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