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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

No Placebo-Only Group

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

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My ovarian, fallopian tube, or peritoneal cancer has returned and cannot be cured with standard treatments.

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My condition responds to or resists platinum-based treatment.

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I have a confirmed genetic mutation in either the BRCA1 or BRCA2 gene.

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I have had platinum-based chemotherapy before for my cancer.

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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:

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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.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My heart's electrical activity (QTc) is prolonged, or I have a family history of long QT syndrome.

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I am not taking strong CYP3A4 inhibitor medications.

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I do not have any infections that need antibiotics.

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I have lasting side effects from cancer treatment, but not hair loss.

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I have been treated with anti-CTLA-4 antibody therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3070

Olaparib

2007

Completed Phase 4

~2190