Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Sorafenib

Topoisomerase I Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Intravenous infusion irinotecan 180 mg/m2 over 90 minutes (D1=D15) with cross over to irinotecan and sorafenib combination at progression.

Oral sorafenib 400 mg twice daily (total dose 800 mg/day) with cross over to irinotecan and sorafenib combination at progression

Intravenous infusion irinotecan 120 mg/m2 over 90 minutes (D1=D15) at Cycle 1, 150 mg/m² at C2 if no diarrhea \> grade 1 and no other toxicity \> grade 2, and 180 mg/m² at C3 in the same conditions

* Oral sorafenib 400 mg twice daily (total dose 800 mg/day) from C1. 1 cycle = 15 days and 1 course = 4 weeks.

Sorafenib and irinotecan combination

Sorafenib monotherapy

Irinotecan monotherapy

Emmanuelle SAMALIN, MD

Marc YCHOU, MD,

The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.

Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

A Randomized Phase II Trial Assessing Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors After Failure of All Drugs Known to be Effective

To evaluate the non-progression rate at 2 months according to RECIST criteria (Version 1.1)

According to RECIST criteria (Version 1.1)

Overall survival is defined as the time from the date of inclusion to the date of death from any cause.

Progression Free Survival is defined as the time from the date of inclusion to first documentation of objective tumor progression or to death due to progression.

Institut du Cancer de Montpellier - Val d'Aurelle

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy

pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy

Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).

Radiotherapy

Radiofrequency ablation

Neil Segal, MD, PhD

The radiation therapy or ablation that the patient received as standard therapy treated only the tumors that were radiated or ablated. Radiation therapy or ablation plus pembrolizumab might lead to a stronger immune response that may control or destroy tumors that did not receive radiation therapy or ablation. The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on the patient, and the cancer that did not receive radiation therapy or ablation.

Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

Single Arm Phase II Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

If at the end of the study ≥3 tumor responses per RECIST 1.1 are observed in a cohort, then further investigation of pembrolizumab plus RT and/or pembrolizumab plus ablation will be considered worthwhile.

All recorded toxicity will be listed and tabulated by system organ class, preferred term and treatment. Any significant vital signs and clinical laboratory test results will be listed and summarized. Any significant physical examination findings, and clinical laboratory results will be listed. Will be recorded according to "Common Terminology Criteria for Adverse Events" V4.0 (CTCAE).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors	NCT01715441	Metastatic Colo...	Sorafenib and i... Sorafenib monot... Irinotecan mono...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients	NCT02437071	Metastatic Colo...	Pembrolizumab Radiotherapy Radiofrequency ...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for metastatic colorectal cancer patients