What side effects are associated with this type of intervention?

Common side effects of pembrolizumab, a PD-1 inhibitor used in cervical cancer treatment, include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Olaparib, a PARP inhibitor, is associated with side effects like nausea, fatigue, anemia, leukopenia, and thrombocytopenia. Patients receiving these treatments may experience a combination of these adverse effects, and it is important to monitor and manage them under the guidance of a healthcare provider.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of advanced cervical cancer based on its demonstrated durable antitumor activity and manageable safety profile in clinical trials. Olaparib, a PARP inhibitor, is being studied in combination with pembrolizumab for advanced or recurrent cervical carcinoma, although specific FDA approval for this combination in cervical cancer has not been detailed. These treatments represent a shift towards targeted and immunotherapy approaches in managing advanced cervical cancer.

What other types of research exist?

Promising novel alternatives for cervical cancer treatment in 2024 include: 1) Nivolumab (another PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in other cancers and is being explored in cervical cancer. 2) Tisotumab vedotin, an antibody-drug conjugate targeting tissue factor, which has demonstrated promising results in clinical trials. 3) Adoptive T-cell therapies, such as tumor-infiltrating lymphocytes (TILs), which are being investigated for their potential to enhance immune response against cervical cancer.

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PARP Inhibitor

Pembrolizumab + Olaparib for Cervical Cancer

Phase 2

Waitlist Available

Led By John P. Diaz, MD

Research Sponsored by John Diaz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed prior to the first dose of treatment.

Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment. Before patients can be enrolled, they must have normal laboratory values as outlined in Table 1. Labs must also fall within normal limits prior to infusion.

Must not have

Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or other T-cell receptor agents

WOCBP with positive pregnancy test within 72 hours prior to the first dose of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, pembrolizumab and olaparib, in patients with advanced or recurrent cervical cancer who have already had chemotherapy. Pembrolizumab helps the immune system fight the cancer, while olaparib stops cancer cells from repairing themselves. Olaparib has been approved for use in various cancers, including ovarian and breast cancer. The goal is to find a more effective treatment for these patients.

Who is the study for?

This trial is for women aged 18+ with advanced or recurrent cervical cancer who've had ≤2 chemo treatments. They must not be pregnant, breastfeeding, and if of childbearing potential, agree to contraception. Participants need a life expectancy ≥16 weeks and adequate organ function as per specific criteria.

What is being tested?

The study tests the combination of pembrolizumab (an immunotherapy drug) and olaparib (a targeted therapy drug) in patients with cervical cancer that has returned or spread after standard chemotherapy. It's an open-label phase II trial where all participants receive the drugs.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, blood count changes increasing infection risk. Specific side effects from each drug may vary based on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My recent lab tests show my organs are functioning well.

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I can carry out all my daily activities without help.

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My cervical cancer has come back and cannot be cured with just surgery or radiation.

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I am a woman over 18 with a confirmed diagnosis of cervical cancer.

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I have provided a sample of my tumor for testing.

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I am a woman over 18 with a confirmed diagnosis of cervical cancer.

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I am a female with cervical cancer.

Exclusion Criteria

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

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I have been treated with specific immune therapy drugs before.

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I am a woman of childbearing potential and not pregnant.

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I have a serious health condition that is not under control.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have been diagnosed with HIV.

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I have not had major surgery in the last 2 weeks.

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I have had pneumonitis treated with steroids or have it now.

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I am not taking strong or moderate drugs that affect enzyme CYP3A.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I am currently on medication for an infection.

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I have active brain metastases or cancer in the lining of my brain.

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I have a history of Hepatitis B or currently have Hepatitis C.

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I have an active tuberculosis infection.

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I have long-lasting side effects from cancer treatment that are moderate or worse.

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I have had a transplant of tissue, organ, or bone marrow from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Immune overall response rate

Secondary study objectives

Duration of response

Therapeutic procedure

Number of patients with baseline tumor deficiencies

+1 more

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: TreatmentExperimental Treatment2 Interventions

PD-1 inhibitor pembrolizumab, in combination with the PARP inhibitor olaparib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~6070

olaparib

2009

Completed Phase 3

~990

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to fight cervical cancer by blocking the PD-1 pathway, which cancer cells use to evade immune detection. Olaparib, a PARP inhibitor, induces cancer cell death by preventing DNA repair, particularly effective in cells with existing DNA repair deficiencies. These targeted treatments are significant for cervical cancer patients as they offer more precise and potentially more effective options with fewer side effects compared to conventional chemotherapy.