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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

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent

Patients who have previously received anti-CTLA-4 antibody therapy

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

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious ongoing illnesses that could affect my participation in the study.

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I have received anti-CTLA-4 antibody therapy before.

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I haven't taken immunosuppressive drugs in the last 14 days.

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I do not show signs of blood disorders like MDS or AML.

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I have not had a blood transfusion in the last 28 days.

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I have not received any live vaccines in the last 30 days.

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I have not had any type of organ or tissue transplant from a donor.

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I regularly take drugs that weaken my immune system for cancer or other illnesses.

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I am not currently taking strong CYP3A4 inhibitors or inducers.

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I do not have a bowel obstruction.

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My ECG shows a QT interval over 470 msec, or I have a family history of long QT syndrome.

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I stopped my cancer hormone therapy at least 28 days ago.

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I have not had major surgery in the last 28 days.

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I do not have significant liver disease like hepatitis or cirrhosis.

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I do not have an active infection needing antibiotics, except for simple UTIs.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the median follow-up is 22 months. since the study was stopped early, the follow-up time frame for objective response was significantly reduced. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicity (DLT) (Safety Lead-In)

Progression Free Survival (PFS)

Secondary study objectives

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 • 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

Hyperglycaemia

Dizziness

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

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

~1180

Biospecimen Collection

2004

Completed Phase 3

~2030