Study Comparing Relatlimab-Nivolumab Combination with Regorafenib or Trifluridine-Tipiracil for Patients with Advanced Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Metastatic Colorectal Cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The study is comparing the effectiveness of a new treatment combination called Relatlimab + Nivolumab with two existing treatments: Regorafenib and a combination of Trifluridine + Tipiracil, also known as TAS-102. The purpose of the study is to see how well these treatments work for patients who have already tried other therapies.

Participants in the study will be randomly assigned to receive either the new treatment combination or one of the existing treatments. The new treatment, Relatlimab + Nivolumab, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The existing treatments, Regorafenib and TAS-102, are taken as tablets by mouth. The study will monitor participants over a period to assess the impact of these treatments on their cancer.

The trial aims to gather information on how these treatments affect overall survival, which is the length of time patients live after starting the treatment. It will also look at other factors such as the response of the cancer to the treatment and any side effects experienced by participants. This information will help determine the best treatment options for patients with Metastatic Colorectal Cancer who have limited options after previous treatments. The study is expected to continue until 2028.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of metastatic colorectal cancer and previous treatment history.

Documentation of tumor characteristics and KRAS mutation status is required.

2 randomization

Participants are randomly assigned to receive either the relatlimab-nivolumab combination or one of the standard care therapies: regorafenib or TAS-102 (trifluridine and tipiracil).

3 treatment administration

For those receiving the relatlimab-nivolumab combination, the medication is administered through an intravenous infusion.

Participants assigned to regorafenib take 40 mg film-coated tablets orally.

Participants assigned to TAS-102 take either 20 mg/8.19 mg or 15 mg/6.14 mg film-coated tablets orally.

4 treatment schedule

The treatment continues as per the study protocol, with regular monitoring and assessments to evaluate the response to the treatment.

5 monitoring and assessments

Regular assessments are conducted to monitor the disease progression and response to treatment.

These assessments include imaging studies and laboratory tests to evaluate overall health and treatment effects.

6 completion

The study is estimated to conclude by May 31, 2028, with ongoing evaluations of overall survival and other health outcomes.

Who Can Join the Study?

You must have metastatic colorectal cancer, which means the cancer has spread to other parts of the body.
Your cancer must be confirmed as adenocarcinoma, a type of cancer that forms in mucus-secreting glands.
The cancer must be metastatic or recurrent and cannot be removed by surgery at the time of joining the study.
You must have tried standard cancer treatments and either the cancer got worse during or within about 3 months after the last treatment, or you couldn’t tolerate the treatments due to significant side effects.
You need to have enough tumor tissue available for testing and meet the study’s requirements for PD-L1 expression, a protein that can affect how the immune system responds to cancer.
Your KRAS mutation status must be known from previous tests. This is a specific gene change that can affect cancer growth.
You must have cancer that can be measured according to specific guidelines. If the only measurable cancer is in an area that was previously treated with radiation, it must show clear signs of getting worse and be measurable.
Both men and women can participate in the study.
The study includes people who might be considered vulnerable, meaning they may need extra protection or care.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
Patients who have certain medical conditions that might interfere with the study treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments or medications that might interfere with the study cannot participate.
Patients who have a history of severe allergic reactions to the study drugs cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Az Maria Middelares Gent	Gent	Belgium
Centre Francois Baclesse	Caen	France
University Hospital Olomouc	Olomouc	Czechia
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Cmsihbrdj Ukeapbbamrqunw Spuosgeyr	Woluwe-Saint-Lambert	Belgium
Hgzkumpz Vvgt drnxbepi	Barcelona	Spain
Hubixusb Uyzvarwtbghbn dp A Cefrdt	A Coruna Galicia	Spain
Veaeek dsg Rkexr Usncrfipbk Hpsmdckc	Sevilla	Spain
Fefjoomm npvakgudl Mdgts a Hbefxwx	Prague	Czechia
Autj Gnxxlh Ophzuqwj Mhpbdjtfzowwj Nbfxyhpc	Milan	Italy
Rqiuwa Szoen Syunha Uudcqfosuayaqeqgxoa	Lund	Sweden
Unlmcum Uswlimkckz Haekrhys	Uppsala	Sweden
Hktuffyo Cksros Dr Bqbhsuvgk	Barcelona	Spain
Ccryhrr Uhzvjvbokpxnhiuxbvkl Bjfeoe Kak	Berlin	Germany
Ivbrn Ohmlfdpo Pubuutrlpcf Sdk Mmqryyh	Genoa	Italy
Uictyhjlqflyhzceyysjx Hyrxknrjye Akv	Heidelberg	Germany
Svhqp Gyzfzl Ssyoprk	Stockholm	Sweden
Kvnearmt dvl Updmwufacjcc Mxgsduvl Ahu	Munich	Germany
Cbmzaq Lffa Blgfco	Lyon	France
Ujbnvmgazyxqevioypjeo Epzoc Ajf	Essen	Germany
Htunjojf Udokflstburwy 1n Dv Ojydmru	Madrid	Spain
Ihvhkyld Cinmad Dhjthxfngqwafepdt	L'hospitalet De Llobregat	Spain
Qepee Stivlh Cfpwjzeju Heenypdd &nhfcjc Stlnvogcpbp Uasvgqffvz Holmgzpp &fiyxku Vykcczd Ggxrvkhpvqubbmvljb	Gothenburg	Sweden
Fhycwzzwv Pila Ln Ixoyimvjbtbhz Bhudshbkb Dso Hwbyxpmi Uzturnbulnqno Lf Puq	Madrid	Spain
Fqeeoycszk Iysncoitae Igymhlpa Nmujhqzskia Blqes	Milan	Italy
Kejppptowjg Noolvttn Gauy	Frankfurt	Germany
Izkrggbf Ovjldpnafe Vugepb	Padua	Italy
Htxrsrw Szkjw Aborqof	Paris	France
Mdimtkkcd srwrrl	Horovice	Czechia
Kplgbakjnsosh Rtghyexgjk Gzeh	Reutlingen	Germany
Ptelonnyw Ioskbclk Mdkvjuup Mztqxtivxutt Siufm Wweudttlcoqd I Agozracgecalr	Warsaw	Poland
Pllfnh Stnc	Skorzewo	Poland
Nlpzcsbw Indgmbdj Ommdwksxm Iiz Msrib Slbjnwnjeiotozsbcuakhcbapahy Ifosoonq Bvusmnbv	Cracow	Poland
Aqupdyw Umc Ivtbb Dy Reldej Ettpjs	Reggio Emilia	Italy
Njvbidvlujp Cchwao Inrhamkme	Amsterdam	The Netherlands
Hluufeeq Fgcr	Suresnes	France
Ibsd Cjqdesc Jpj	Levallois-Perret	France
Apczi Gtewyukew Dk Celiotq	Catania	Italy
Srwp Ctkzs Gekrgyifdq	Salzburg	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	31.03.2022
Belgium	Not recruiting	31.03.2022
Czechia	Not recruiting	31.03.2022
France	Not recruiting	31.03.2022
Germany	Not recruiting	31.03.2022
Italy	Not recruiting	31.03.2022
Poland	Not recruiting	31.03.2022
Spain	Not recruiting	31.03.2022
Sweden	Not recruiting	31.03.2022
The Netherlands	Not recruiting	31.03.2022

Trial locations

Investigated Drugs:

Relatlimab-nivolumab Fixed-dose Combination is a combination of two medications used together to help the immune system fight cancer. Relatlimab and nivolumab are both types of drugs called immune checkpoint inhibitors. They work by blocking certain proteins on cancer cells, which helps the immune system recognize and attack the cancer.

Regorafenib is a medication used to treat certain types of cancer by blocking proteins that help cancer cells grow. It is often used when other treatments have not been successful. Regorafenib works by slowing down the growth and spread of cancer cells.

Trifluridine + Tipiracil (TAS-102) is a combination of two drugs used to treat cancer. Trifluridine is a type of chemotherapy that interferes with the DNA of cancer cells, preventing them from growing and dividing. Tipiracil helps increase the effectiveness of trifluridine by preventing its breakdown in the body. Together, they work to slow down the growth of cancer cells.

Investigated Diseases:

Colorectal cancer metastatic

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease can cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it may lead to more severe symptoms depending on the organs affected. The progression can vary greatly among individuals, with some experiencing rapid spread while others have a slower course. Understanding the specific pathways and mechanisms of spread is crucial for managing the disease.

Trial ID:

2023-503797-21-00

Protocol code:

CA224-123

NCT ID:

NCT05328908

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Relatlimab-Nivolumab Combination with Regorafenib or Trifluridine-Tipiracil for Patients with Advanced Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?