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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
Must not have
Hormonal therapy directed at treatment for the cancer must be discontinued at least 1 week prior to enrollment
Any prior radiation therapy must be discontinued at least 4 weeks prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I stopped my cancer hormone therapy at least a week ago.
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I stopped any radiation therapy at least 4 weeks ago.
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I do not have an autoimmune disorder requiring steroids or immunosuppressants, except for vitiligo.
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I regularly take drugs that suppress my immune system.
Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
My heart's electrical activity (QTc) is prolonged, or I have a family history of long QT syndrome.
Select...
I am not taking strong CYP3A4 inhibitor medications.
Select...
I do not have any infections that need antibiotics.
Select...
I have lasting side effects from cancer treatment, but not hair loss.
Select...
I have been treated with anti-CTLA-4 antibody therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 2: Objective response rate (ORR)
Secondary study objectives
Phase 2: Progression free survival (PFS)

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
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%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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
~3130
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

New Mexico Cancer Care AllianceLead Sponsor
70 Previous Clinical Trials
52,409 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

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02571725 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Olaparib and Tremelimumab
Ovarian Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT02571725 — Phase 1 & 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02571725 — Phase 1 & 2
~5 spots leftby Sep 2025
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