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A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

Primary Objective:
To determine whether atezolizumab combined with FOLFOX and its continuation as
monotherapy can significantly improve DFS compared to FOLFOX alone in patients with stage III colon cancers and dMMR.

Secondary Objectives:
1. To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR.

2. To assess the adverse events (AE) profile and safety of each treatment arm, using the CTCAE and PRO-CTCAE

Quality of Life Objective:
The quality of life objective will be to determine the impact of the addition of atezolizumab to FOLFOX on patient-reported neuropathy, health-related QOL, and functional domains of health-related QOL. The quality of life analysis will also access the efficacy of atezolizumab adjusting for baseline QOL and fatigue measurements.

Potential Correlative Science Objectives:
1..Testing of banked specimens will not occur until an amendment to this treatment protocol (or separate correlative science protocol) is reviewed and approved in accordance with National Clinical Trials Network (NCTN) policies.

2. To determine if the Immunoscore can predict the efficacy of atezolizumab for disease free survival among patients with stage III colon cancer.

3. To assess whether circulating immune cell populations can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer.

4. To explore the associations of genomic alterations identified in cfDNA with DFS in patients treated with FOLFOX with or without atezolizumab.

5. To assess whether soluble markers of systemic inflammation in blood can predict the efficacy of atezolizumab as adjuvant therapy for stage III colon cancer.

6. To assess the relationship between baseline plasma 25(OH) D levels, change in 25(OH)D levels, and DFS and OS in patients with stage III colon cancer receiving FOLFOX +/- atezolizumab.

7..To determine the ability of using fecal microbiota and their metabolic products to predict survival benefit from anti-PD-L1 antibody therapy in dMMR colon cancer patients.

8. To determine if hypermutation or hyper-indel status is associated with response to atezolizumab.

9. To determine if unique mRNA expression signatures are predictive of disease-free survival among patients receiving adjuvant chemotherapy for stage III colon cancer.

10. To determine if the efficacy of atezolizumab differs among dMMR cancers due to germline MMR mutation (MLH1, MSH2, MSH6, PMS2) versus those with MLH1
hypermethylation and CIMP in patients with stage III colon cancer.

11. To identify overall mutational burden and number of putative tumor neoantigens in colon carcinoma specimens.

Protocol Number: 071808
Phase: Phase III
Applicable Disease Sites: Colon
Drugs Involved: Atezolizumab (MPDL3280A)
mFOLFOX6
Principal Investigator: Howard Hochster M.D
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
    • Principal Investigator
      • Howard Hochster M.D
  • Morristown Medical Center
  • RWJBarnabas Health
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-7356.