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Study of Pembrolizumab and Olaparib for Patients with Advanced Colorectal Cancer with DNA Repair Deficiency

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What is this study about?

This clinical trial is focused on studying treatments for advanced colorectal cancer, a type of cancer that affects the colon or rectum. The study involves two medications: Pembrolizumab and Olaparib. Pembrolizumab, also known by its code name MK-3475, is a medication given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Olaparib is taken orally in the form of film-coated tablets. The purpose of the study is to evaluate how well these medications work together in patients with a specific type of colorectal cancer that has a deficiency in DNA repair, known as homologous-recombination deficiency (HRD).

Participants in the study will receive a combination of Pembrolizumab and Olaparib. The study will monitor the response of the cancer to this treatment over a period of time. The treatment period for Pembrolizumab is up to 24 months, while Olaparib is administered for up to 42 months. The study aims to determine the effectiveness of this combination in controlling the disease and improving outcomes for patients with this specific type of colorectal cancer.

Throughout the study, participants will undergo regular assessments to track the progress of their cancer and any changes in their condition. These assessments will help researchers understand the impact of the treatment on the cancer and gather important information about the potential benefits and risks of using Pembrolizumab and Olaparib together. The study is designed to provide valuable insights into new treatment options for patients with advanced colorectal cancer that has specific genetic characteristics.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood samples are collected to ensure adequate organ function. This must occur within 7 days before starting the study treatment.

2 treatment initiation

The treatment involves two medications: pembrolizumab and olaparib.

Pembrolizumab is administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

Olaparib is taken orally in the form of film-coated tablets. The dosage and frequency are specified in the study protocol.

3 treatment monitoring

Regular monitoring is conducted to assess the response to treatment. This includes imaging studies and laboratory tests.

The objective is to evaluate the response rate of the treatment using specific criteria.

4 follow-up assessments

Follow-up assessments are scheduled to monitor disease progression and overall health.

These assessments help determine the duration of response and any potential side effects.

5 completion of trial

The trial is estimated to conclude by February 14, 2025.

Final assessments are conducted to gather data on the effectiveness and safety of the treatment.

Who Can Join the Study?

  • Participants must be at least 18 years old and have a confirmed diagnosis of colorectal cancer.
  • Participants should have an ECOG performance status of 0 to 1, which means they should be fully active or have some symptoms but can still carry out light work. This assessment should be done within 7 days before starting the study treatment.
  • Participants must have proper organ function, which will be checked through blood tests taken within 7 days before starting the study treatment.
  • Participants should have unresectable (cannot be removed by surgery) locally-advanced or metastatic colorectal cancer (cancer that has spread to other parts of the body) and have shown disease progression confirmed by imaging tests.
  • Participants must have a specific type of genetic change called DNA HRD. This can be identified by certain genetic tests. If these tests show the required genetic changes, participants may be eligible for the study. If the first test is positive, a new biopsy (tissue sample) may be needed before starting the study treatment.
  • A previous tumor tissue sample is needed to confirm the HRD status using a validated test. This sample should not have been exposed to radiation before.
  • Participants must have received between 2 to 5 previous treatments for their cancer, including specific drugs like fluoropyrimidines, oxaliplatin, and irinotecan. They may have also received other treatments if their cancer type is suitable.
  • Participants must have received oxaliplatin-based chemotherapy in a setting where surgery was not possible and shown sensitivity to this treatment. This means they should have received a certain number of treatment cycles and had a period without disease progression for at least 9 months after the last treatment.
  • Participants with both MSS (microsatellite stable) or MSI-H (microsatellite instability-high) advanced colorectal cancer can join the study.
  • Participants or their legal representatives must provide written consent to join the study.
  • Participants must have measurable disease based on specific criteria (RECIST 1.1). If the cancer is in an area that was previously treated with radiation, it must have shown progression after the treatment to be considered measurable.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than colorectal cancer cannot participate.
  • Patients who do not have refractory metastatic colorectal cancer cannot participate. This means the cancer has spread to other parts of the body and is not responding to treatment.
  • Patients without DNA homologous-recombination-repair deficiency (HRD) cannot participate. This is a specific genetic condition where the DNA repair process is not working properly.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hzpuzuot Uglzsipqfdrkz Mbitzdj Dv Vjcdaqdjra Santander Spain
Phft Tdsat Hobwoxnm Uzsxbhufuvmk Sabadell Spain
Hyioedfv Dw Ls Socow Clci I Sudy Pin Barcelona Spain
Fjymxdymb Pspb Ls Ilhkzsymhqtgi Bkazakuzv Dsq Hoqclsdm Uvxzxkmruhhge Lr Ptx Madrid Spain
Hvjamegd Vzbx dxlonzuv Barcelona Spain
Hdydvuqu Uwvkypyfbkurq dy A Ctkypz A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.11.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy that helps the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this trial, pembrolizumab is being used to treat advanced colorectal cancer.

Olaparib is a medication that targets cancer cells with specific genetic defects, such as those with homologous-recombination-repair deficiency. It works by interfering with the cancer cells’ ability to repair their DNA, leading to cell death. In this trial, olaparib is used in combination with pembrolizumab to treat patients with advanced colorectal cancer.

Investigated diseases:

Colorectal cancer – This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and damage nearby tissues and organs. It may also spread to other parts of the body, such as the liver or lungs, through the bloodstream or lymphatic system. Symptoms can include changes in bowel habits, blood in the stool, and abdominal discomfort.

Trial ID:
2023-509095-42-00
Protocol code:
GEMCAD 2102
NCT ID:
NCT05201612
Trial Phase:
Therapeutic exploratory (Phase II)

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