Atezolizumab in Patients With MSI-h/MMR-D Stage III Colorectal Cancer

Status Recruiting

Clinical Trial Summary

The investigators hypothesize that atezolizumab will improve the prognosis of patients with stage III dMMR CRC ineligible for or refusing oxaliplatin-based adjuvant chemotherapy compared to SOC and that these could therefore be promising therapeutic options.

Clinical Trial Description

The current standard of care for adjuvant treatment of oxaliplatin-ineligible patients with stage III dMMR colon cancer is fluoropyrimidine monotherapy. In the COLOPREDICT registry, the 3 years DFS rate for such patients >70 years of age is 63% (95%CI: 53-75%). In contrast to patients with mismatch repair proficient (pMMR) colon cancer, however, it is not established whether patients with stage III dMMR colon cancer benefit from adjuvant fluoropyrimidine monotherapy at all. For patients with stage II colon cancer in an otherwise identical setting, there is no indication for adjuvant treatment due to a lack of clinical benefit compared to surgery alone. Clinical results suggests a similar situation for stage III malignancy. Siwemilar to other checkpoint inhibitors (CPI), the PD-L1 antibody atezolizumab demonstrated impressive activity and good tolerability in patients with metastatic dMMR CRC. Recently, the randomized phase III Keynote-177 trial was presented. In Keynote-177, patients with dMMR metastatic CRC were randomized to the PD-1 antibody pembrolizumab or to chemotherapy (mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab as per Investigator's choice). Pembrolizumab treatment resulted in a statistically significant prolongation of Progression-free survival . In addition, side effects were lower with pembrolizumab and quality of life was improved compared to conventional chemotherapy. Thus, pembrolizumab will become the new standard of care in patients with dMMR metastatic CRC in first-line therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05118724
Study type	Interventional
Source	AIO-Studien-gGmbH
Contact	Caroline Kühl
Phone	+49 30 8145 344 74
Email	caroline.kuehl@aio-studien-ggmbh.de
Status	Recruiting
Phase	Phase 2
Start date	December 10, 2021
Completion date	November 15, 2026

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Completed	`NCT00098787` - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer	Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05425940` - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	Phase 3
Suspended	`NCT04595604` - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.	N/A
Completed	`NCT03414125` - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	N/A
Completed	`NCT02963831` - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies	Phase 1/Phase 2
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Terminated	`NCT01847599` - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib	N/A
Recruiting	`NCT03874026` - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients	Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Completed	`NCT03181334` - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation	N/A
Completed	`NCT03167125` - Participatory Research to Advance Colon Cancer Prevention	N/A
Recruiting	`NCT04258137` - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study	N/A
Not yet recruiting	`NCT05775146` - SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases	Phase 2
Recruiting	`NCT05568420` - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting	`NCT02972541` - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer	N/A
Completed	`NCT02876224` - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors	Phase 1
Completed	`NCT01943500` - Collection of Blood Specimens for Circulating Tumor Cell Analysis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Atezolizumab in Patients With MSI-h/MMR-D Stage III Colorectal Cancer Ineligible for Oxaliplatin — ANTONIO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms