Ongoing Clinical Trials for Colorectal Adenocarcinoma
This article provides an overview of 10 ongoing clinical trials focused on colorectal adenocarcinoma, a type of cancer that begins in the glandular cells of the colon or rectum. These trials are exploring various treatment approaches, including targeted therapies, immunotherapies, and chemotherapy combinations, for patients at different stages of the disease. Trials are being conducted across multiple countries in Europe, including Italy, Spain, France, Belgium, Germany, Netherlands, Sweden, Norway, and Slovakia.
Clinical trial locations
- Belgium
- Study on the Safety and Effectiveness of GTAEXS617 for Patients with Advanced Solid Tumors
- Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer
- Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation
- France
- Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer
- Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
- Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation
- Germany
- Italy
- Study of Pre-Operative Treatments with Sotorasib and Drug Combination for Patients with Resectable Colorectal Cancer
- Study on Encorafenib, Cetuximab, and FOLFIRI for Patients with BRAF V600E Mutated Metastatic Colorectal Cancer After Progression on Encorafenib and Cetuximab
- Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer
- Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
- Netherlands
- Norway
- Slovakia
- Spain
- Study on the Effectiveness and Safety of Cetuximab, Encorafenib, and Binimetinib for Patients with Advanced Colorectal Cancer with BRAF V600E Mutation
- Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer
- Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
- Sweden
Study of Pre-Operative Treatments with Sotorasib and Drug Combination for Patients with Resectable Colorectal Cancer
This trial is designed for patients with colorectal cancer that can be surgically removed and who have specific molecular characteristics making them suitable for targeted treatments. The main goal is to evaluate the effectiveness of different short-term treatments given before surgery to see how well they work in reducing or eliminating the cancer.
Main inclusion criteria: Patients must be at least 18 years old with an ECOG performance status of 0 or 1. They should have a confirmed diagnosis of colorectal adenocarcinoma that can be completely removed by surgery, with a specific molecular profile determined by central testing. Adequate bone marrow, kidney, and liver function is required. Patients must not have had previous systemic treatment or radiation therapy for the cancer.
Main exclusion criteria: Patients with any other type of cancer besides the specific type being studied are excluded. Those who have had major surgery within the last 4 weeks, are currently receiving other cancer treatments, have active infections requiring antibiotics, or have known allergies to the study drugs cannot participate. Pregnant or breastfeeding women, patients with serious heart, lung, liver, kidney, or mental health conditions, and those unable to follow study procedures are also excluded.
Trial focus: The trial involves several medications targeting specific molecular features of the cancer, including Sotorasib, Durvalumab, DS-8201a (Trastuzumab Deruxtecan), Panitumumab, Balstilimab, and Botensilimab. Some patients may receive a placebo for comparison. The study will monitor how the cancer responds by examining tumor tissue samples and assess safety, side effects, and quality of life.
Investigational drugs: The study uses UNICORN Study Medications 1 and 2, which are targeted treatments designed to focus on specific molecules, proteins, or genes in cancer cells to disrupt their growth and survival before surgery.
Study on Encorafenib, Cetuximab, and FOLFIRI for Patients with BRAF V600E Mutated Metastatic Colorectal Cancer After Progression on Encorafenib and Cetuximab
This trial focuses on patients with metastatic colorectal cancer that has a specific genetic change called the BRAF V600E mutation. The study tests whether adding FOLFIRI chemotherapy to encorafenib and cetuximab can help patients whose cancer has continued to grow despite previous treatment with these two drugs.
Main inclusion criteria: Patients must be at least 18 years old with adequate bone marrow, kidney, liver, and heart function. They should be able to take oral medications and have a life expectancy of at least 3 months. Patients must have confirmed metastatic colorectal adenocarcinoma with a BRAF V600E mutation and have experienced disease progression while on treatment with encorafenib and cetuximab in the second line setting. They must have had at least a stable disease response lasting 3 months to the previous treatment.
Main exclusion criteria: Patients without the BRAF V600E mutation, those who have not previously been treated with the drug combination and FOLFIRI, those outside the specified age range, and vulnerable populations are excluded.
Trial focus: The study evaluates whether the combination of encorafenib, cetuximab, and FOLFIRI (including irinotecan, fluorouracil, and folinic acid) can help patients live longer without their cancer getting worse. The primary goal is to assess the 6-month progression-free survival rate.
Investigational drugs: Encorafenib targets and inhibits the BRAF protein, cetuximab blocks the EGFR protein on cancer cells, and FOLFIRI is a chemotherapy combination that interferes with cancer cell DNA to prevent growth and division.
Study on the Effectiveness and Safety of Cetuximab, Encorafenib, and Binimetinib for Patients with Advanced Colorectal Cancer with BRAF V600E Mutation
This trial investigates a treatment combination for patients with advanced colorectal cancer that has the BRAF V600E mutation and is microsatellite stable. The goal is to see if the combination can make the cancer more manageable and possibly allow for surgical removal or other curative treatments.
Main inclusion criteria: Patients must be at least 18 years old with good bone marrow, liver, and kidney function. They should be able to swallow oral medications and have an ECOG performance status of 0 or 1. Patients must have confirmed colorectal adenocarcinoma with a BRAF V600E mutation and microsatellite stable disease. The cancer must be either locally advanced and potentially resectable, have limited metastases, or have recurred after previous surgery and chemotherapy.
Main exclusion criteria: Patients without the specific BRAF V600E mutation and microsatellite stable characteristics, those whose cancer is not initially resectable or potentially resectable, those outside the specified age range, and vulnerable populations are excluded.
Trial focus: The study evaluates the effectiveness of combining cetuximab, encorafenib, and binimetinib as an initial treatment. The medications are administered over time, with regular monitoring to determine if the treatment can shrink the cancer enough to allow for surgery or other procedures aimed at curing the disease.
Investigational drugs: Cetuximab targets proteins on cancer cell surfaces, encorafenib blocks the BRAF V600E mutation, and binimetinib targets a different pathway in cancer cells to further inhibit their growth.
Study on the Safety and Effectiveness of GTAEXS617 for Patients with Advanced Solid Tumors
This trial studies a new treatment called GTAEXS617 for patients with advanced solid tumors, including colorectal cancer. The study aims to understand how safe the treatment is and how it behaves in the body, as well as its potential to fight cancer.
Main inclusion criteria: Patients must be at least 18 years old with an ECOG performance status of 0-1 and an estimated life expectancy of more than 3 months. They should be able to swallow and retain oral medication. Patients must have confirmed advanced solid tumors, including colorectal cancer, that has progressed after standard treatments or for which they cannot tolerate standard therapy. Adequate blood, liver, and kidney function is required.
Main exclusion criteria: Patients with advanced solid tumors who are not within the specified age range or who are part of vulnerable populations cannot participate.
Trial focus: The study is conducted in two main parts. In the first part, GTAEXS617 is given alone to determine safety and the best dose. In the second part, it is combined with standard treatments to assess its effectiveness when used together.
Investigational drugs: GTAEXS617 is a new medication being tested in tablet form. It is designed to help treat advanced solid tumors by targeting specific aspects of cancer cell growth.
Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer
This trial focuses on treating advanced stage HER2-positive cancers, including colorectal cancer. The study involves a new medication called ELVN-002 tested in combination with trastuzumab and, in some cases, additional chemotherapy drugs.
Main inclusion criteria: Participants must be 18 years or older with a confirmed solid tumor that is HER2 positive. The disease must be locally advanced, relapsed/refractory, or unresectable metastatic. Patients must have had prior treatment and have at least one measurable lesion. An ECOG performance status of 0-1 and adequate heart function (LVEF of 50% or higher) are required.
Main exclusion criteria: Patients with cancers other than solid tumors, colorectal cancer, or breast cancer, those without advanced stage HER2 positive cancer, those outside the specified age range, those unable to safely receive study treatments, and vulnerable populations are excluded.
Trial focus: The study evaluates the safety and tolerability of ELVN-002 combined with trastuzumab and various chemotherapy regimens. For colorectal cancer, this may include CAPEOX or mFOLFOX6. The trial is divided into Phase 1a (safety and dose determination) and Phase 1b (broader safety evaluation).
Investigational drugs: ELVN-002 is being tested for safety and effectiveness in treating HER2 positive cancers. Trastuzumab targets the HER2 protein to block cancer cell growth. Additional chemotherapy drugs include capecitabine, oxaliplatin, fluorouracil, and leucovorin.
Study of INCB099280 and Ipilimumab for Patients with Advanced Solid Tumors
This trial studies the effects of a new treatment combination for people with certain types of solid tumors. The study involves INCB099280, taken as a tablet, and ipilimumab, given as an intravenous infusion.
Main inclusion criteria: Patients must be 18 years or older and able to sign informed consent. They should have an ECOG performance score of 0 or 1 and a life expectancy of more than 3 months. Patients must have confirmed solid tumors that can be measured and have had previous treatments. They must be willing to follow all study requirements, including swallowing pills. Both males and females must agree to avoid pregnancy or fathering children during the study and for a specified period afterward.
Main exclusion criteria: Participants with solid tumors who are not within the specified age range or who do not meet the safety and tolerability requirements are excluded. Vulnerable populations may also be excluded.
Trial focus: The purpose is to determine how safe and tolerable this treatment combination is for patients. The study will monitor participants for side effects and assess the impact on tumor growth. The goal is to find the right dose that is both safe and effective.
Investigational drugs: INCB099280 is an investigational medication being studied for safety and tolerability. Ipilimumab is an immunotherapy that helps the immune system fight cancer by blocking a specific protein on T-cells.
Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
This trial studies the effects of tisotumab vedotin on patients with locally advanced or metastatic solid tumors, including colorectal cancer. The study evaluates how well the drug works on its own and in combination with pembrolizumab and platinum-based chemotherapy.
Main inclusion criteria: Patients must have relapsed, locally advanced, or metastatic colorectal cancer (or other specified cancers) that has not responded to previous treatments. They must have measurable disease and be able to provide a tissue sample for testing. Both men and women of various age ranges can participate.
Main exclusion criteria: Patients with cancers other than solid tumors, those without locally advanced or metastatic disease, those outside the specified age range, those unable to follow study procedures, and vulnerable populations are excluded.
Trial focus: The study is divided into several parts. Some patients receive tisotumab vedotin alone, while others receive it with pembrolizumab or with both pembrolizumab and a platinum agent like cisplatin or carboplatin. The medications are administered through intravenous infusion. The study monitors tumor response, time to response, and overall survival.
Investigational drugs: Tisotumab vedotin is being tested for its ability to fight cancer. Pembrolizumab helps the immune system attack cancer cells. Platinum agents are chemotherapy drugs that damage cancer cell DNA.
Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
This trial focuses on patients with high-risk stage II or stage III colorectal cancer who have tumors that are MSI-high or MMR-deficient and cannot receive oxaliplatin chemotherapy. The study tests whether atezolizumab can improve the chances of staying cancer-free for three years after treatment.
Main inclusion criteria: Patients must be at least 18 years old and provide written informed consent. They should have adequate blood counts, liver enzymes, and kidney function, and be willing to follow the study protocol. Patients must have confirmed colorectal adenocarcinoma that is high-risk stage II or stage III, with tumors that are MSI-high or MMR-deficient. The tumor must have been removed with successful surgery or be planned for removal. An ECOG status of 0 to 2 is required.
Main exclusion criteria: Patients with different types of cancer, those who have already received oxaliplatin-based chemotherapy, those who have not had or do not plan to have their tumor removed, those unwilling to follow study procedures, and those with other serious health conditions are excluded. Pregnant or breastfeeding women and those participating in other clinical trials are also excluded.
Trial focus: The treatment involves atezolizumab given as an intravenous infusion for up to 12 months. The study includes a comparison with a placebo to evaluate the effectiveness of atezolizumab. Participants are closely monitored for side effects and changes in their condition.
Investigational drugs: Atezolizumab is an immunotherapy medication that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein.
Study on Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, Oxaliplatin, and Floxuridine for Patients with Colorectal Cancer Spread to the Liver
This trial studies treatments for colorectal cancer that has spread to the liver. The study combines hepatic arterial infusion pump (HAIP) chemotherapy, which delivers drugs directly to the liver, with systemic chemotherapy given through the bloodstream.
Main inclusion criteria: Patients must be at least 18 years old with adequate bone marrow, liver, and kidney function. They should provide written informed consent and have an ECOG performance status of 0 or 1 with a life expectancy of at least 12 weeks. Patients must have confirmed colorectal adenocarcinoma that requires first or second line systemic therapy. The cancer must be potentially resectable, and it must be technically possible to place a catheter for HAIP chemotherapy. Patients must be eligible for abdominal surgery.
Main exclusion criteria: Patients with any medical condition other than colorectal adenocarcinoma, those with cancer spread beyond the liver, those outside the specified age range, and vulnerable populations are excluded.
Trial focus: The study evaluates the feasibility of combining HAIP chemotherapy with systemic chemotherapy regimens such as FOLFOX and FOLFIRI. The goal is to determine how well patients tolerate the treatments and whether the cancer becomes operable. The study monitors side effects and complications over a period of up to six months.
Investigational drugs: FOLFOX includes 5-fluorouracil, leucovorin, and oxaliplatin. FOLFIRI includes 5-fluorouracil, leucovorin, and irinotecan. These combinations work to stop cancer cells from growing and dividing.
Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation
This trial evaluates how long disease can be controlled with treatment for patients with metastatic colorectal adenocarcinoma without a RAS mutation. The treatment combines FOLFOX chemotherapy with panitumumab using a “stop-and-go” strategy.
Main inclusion criteria: Patients must have metastatic colorectal adenocarcinoma without RAS mutation. They should have a prothrombin time greater than 60%, albumin level of at least 25 g/L, and a life expectancy of at least 3 months. Patients must be part of a social security scheme, informed about the study, and have signed consent. The cancer must be confirmed as stage IV and not removable by surgery. At least one tumor must be measurable. Patients must be 18 years or older with a WHO performance status of 2 or less. Adequate blood cell counts, kidney function, and liver enzyme levels are required.
Main exclusion criteria: Patients with other types of cancer, those outside the specified age range, vulnerable populations, and those not meeting specific health requirements are excluded.
Trial focus: The study uses a combination of FOLFOX chemotherapy and panitumumab with a “stop-and-go” approach, meaning treatment is paused and restarted based on disease progression. The trial evaluates duration of disease control, progression-free survival, tumor response, overall survival, and quality of life.
Investigational drugs: FOLFOX includes folinic acid, fluorouracil, and oxaliplatin, which interfere with cancer cell growth. Panitumumab is a monoclonal antibody that targets the EGFR protein on cancer cells to prevent their growth and division.
Summary
These 10 clinical trials represent diverse approaches to treating colorectal adenocarcinoma at various stages of disease progression. Several trials focus on patients with specific genetic mutations, particularly the BRAF V600E mutation, reflecting the growing importance of personalized medicine in cancer treatment. The trials are geographically distributed across Europe, with notable concentration in countries like Italy, France, Spain, and Belgium, indicating strong research infrastructure in these regions.
Treatment approaches vary considerably, from pre-operative targeted therapies for resectable disease to combination regimens for advanced metastatic cancer. Many trials incorporate immunotherapies and targeted agents alongside traditional chemotherapy, representing the evolution of treatment strategies. The emphasis on combination therapies, particularly those pairing targeted agents with chemotherapy or immunotherapy, suggests a strategic shift toward multi-modal treatment approaches.
Several trials specifically address patient populations who cannot tolerate standard treatments, such as oxaliplatin-based chemotherapy, highlighting efforts to develop alternative options for these underserved groups. The inclusion of quality of life assessments in many trials demonstrates recognition of the importance of patient experience alongside clinical outcomes. These studies collectively contribute to advancing treatment options and understanding optimal therapeutic strategies for patients with colorectal adenocarcinoma.
