Colon Carcinoma Clinical Trial
Official title:
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)
In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be approximately 6 weeks.
In this multi-center, open-label, exploratory study, the investigators will enroll 60 patients within two years, including 30 patients with MSS tumors and 30 patients with MSI tumors. Patients with MSS tumors will be randomized to either group 1 or 2. Patients with MSI tumors will all be allocated to group 1. Patients in group 1 will be treated with a single dose of ipilimumab 1mg/kg on day 1 and two cycles of nivolumab 3mg/kg on day 1 and 15, respectively. Patients in group 2 will be treated with a single dose of ipilimumab 1mg/kg on day 1, two cycles of nivolumab 3mg/kg one day 1 and 15 and celecoxib daily until the day before surgery. The study was amended in May 2020 to enroll an additional 70 patients in the MSI cohort after the first 30 patients, making a total of 100 patients with MSI tumors. A formal sample size calculation and primary endpoint of 3-year disease-free-survival (DFS) for this group was added. The study was amended in July 2021 to add a new cohort, cohort 4, for patients with pMMR/MSS tumors. Once accrual of 30 evaluable patients in group 2 was completed, a new cohort opened in which patients will receive nivolumab plus anti-IL8 (BMS-986253). The study was amended in November 2022 to add cohort 5 and 6, both in which patients will receive nivolumab plus relatlimab (anti-LAG3). Patients with pMMR/MSS tumors will be randomized 1:1 between cohort 4 and cohort 5, patients with dMMR/MSI tumors will be enrolled in cohort 6. Accrual for cohort 4 was reached in July 2023. In April 2024, accrual for cohort 6 was reached. Per April 2024 only cohort 5 is open for recruitment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05280379 -
Trained Immunity in Thyroid Carcinoma and Colon Carcinoma
|
||
| Completed |
NCT01896778 -
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
|
N/A | |
| Terminated |
NCT01111292 -
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT00996619 -
Measuring the Spectrum of Tissues During Endoscopy
|
N/A | |
| Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
| Recruiting |
NCT04147494 -
Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
|
Early Phase 1 | |
| Active, not recruiting |
NCT02991092 -
The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)
|
N/A | |
| Active, not recruiting |
NCT01696981 -
Screening for Colorectal Cancer in Older Patients (PLCO Screening Trial)
|
N/A | |
| Terminated |
NCT03137706 -
Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
|
||
| Active, not recruiting |
NCT03151564 -
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
|
N/A | |
| Recruiting |
NCT04959604 -
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
|
N/A | |
| Completed |
NCT02890758 -
Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803
|
Phase 1 | |
| Completed |
NCT03064308 -
The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery
|
N/A | |
| Active, not recruiting |
NCT02432963 -
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT04505553 -
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05672342 -
Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
|
Early Phase 1 | |
| Recruiting |
NCT03334383 -
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery
|
N/A | |
| Suspended |
NCT04955808 -
Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
|
||
| Recruiting |
NCT00922688 -
Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients
|
N/A | |
| Completed |
NCT00122135 -
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
|
N/A |