Nivolumab for Colorectal Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Local Institution, San Miguel de Tucumán, Argentina
Colorectal Cancer+2 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a combination of two immunotherapy drugs may help treat colorectal cancer.

See full description

Eligible Conditions

  • Colorectal Cancer
  • Metastatic Colorectal Cancer (CRC)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Colorectal Cancer

Study Objectives

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 19 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Up to 5 years.

Up to 5 years
ORR by BICR (arm A vs C, 1L, centrally confirmed)
ORR by BICR (arm B vs A, 1L, centrally confirmed)
ORR by BICR (arm B vs C, 1L, centrally confirmed)
ORR by BICR (crossover cohort, centrally confirmed)
OS (arm A vs C, 1L, centrally confirmed)
OS (arm B vs A, 1L, centrally confirmed)
OS (arm B vs C, 1L, centrally confirmed)
Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)
Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)
PFS by BICR (arm A vs C, 1L, centrally confirmed)
PFS by BICR (arm B vs A, 1L, centrally confirmed)
PFS by BICR (arm B vs A, all lines, by each central test)
PFS by BICR (arm B vs C, 1L, by each central test)
PFS by BICR (arm B vs C, 1L, centrally confirmed)
PFS by BICR (crossover cohort, centrally confirmed)
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing)
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing)
PFS by Investigator (arm A, B and C, 1L, centrally confirmed)
PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Colorectal Cancer

Trial Design

3 Treatment Groups

Arm C: Investigator's Choice Chemotherapy
1 of 3
Arm B: Nivolumab + Ipilimumab Combination
1 of 3
Arm A: Nivolumab Monotherapy
1 of 3
Active Control
Experimental Treatment

This trial requires 831 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm B: Nivolumab + Ipilimumab CombinationSpecified dose on specified days
Arm A: Nivolumab Monotherapy
Biological
Specified dose on specified days
Arm C: Investigator's Choice ChemotherapyParticipants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

UPMC Hillman Cancer Center - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Colorectal Cancer or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have histologically confirmed recurrent or metastatic colorectal cancer (CRC) and are not eligible for surgery. show original
You have metastatic colorectal cancer and are not eligible for surgery. show original
You have MSI-H or dMMR status per local standard of practice. show original
Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Patient Q&A Section

What are common treatments for microsatellite instability?

"Most patients with microsatellite instability treated in our clinic had no change in cancer risk with the available therapies on the market at the time. Most also required additional treatments, including surgery and/or radiation-based therapy. Results from a recent clinical trial of the present study raise the possibilities of other treatment approaches that could improve survival rate for patients with microsatellite instability." - Anonymous Online Contributor

Unverified Answer

How many people get microsatellite instability a year in the United States?

"In a population-based survey, the presence of MSI was significantly associated with advanced [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) and other tumor types. In particular, MSI was more frequent in subjects with stage III, IV, and distal cancers, and it also was associated with the presence of high-grade and microsatellite-stable cancers. To further explore this phenomenon as a biological marker, patients with microsatellite instability in the future may be considered for adjuvant chemotherapy at the time of surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of microsatellite instability?

"In our study, two-third of colonic lesions in HNPCC had an underlying MSI-like state. We suggest that the presence of MSI-H foci and mismatch repair defects in colonic cells are possible biomarkers for HNPCC. Thus, MSI may be a useful adjunct to the clinical diagnosis of colonic cancer in patients with HNPCC." - Anonymous Online Contributor

Unverified Answer

What causes microsatellite instability?

"Microsatellite Instability seems to be a common problem with colorectal cancers, and is found to occur in about 15% of colonic adenomas. This suggests that this is an important link in a carcinogenic pathway." - Anonymous Online Contributor

Unverified Answer

Can microsatellite instability be cured?

"The vast majority of people with colorectal cancers with stable microsatellite instability show no further malignant disease, but some tumors have changed the genotype when compared to benign adenomas. These changes may be due to underlying differences in gene expression, and in the majority of cases the genetic changes are not evident by conventional methods of gene dosage analysis." - Anonymous Online Contributor

Unverified Answer

What is microsatellite instability?

"Microsatellite instability is a common genetic marker for familial breast and colorectal cancer, possibly due to germline mutations in mismatch repair genes. There is some evidence for germline microsatellite instability being associated with colorectal cancer. Microsatellite instability, as measured by the polymerase chain reaction method, may have clinical usefulness in identifying individuals at risk for breast and colorectal cancer." - Anonymous Online Contributor

Unverified Answer

What is nivolumab?

"It is the first FDA-approved anti-PD-1 therapy for H. pylori-associated gastritis and peptic ulcer disease, but has not yet been determined to be effective in treating gastroesophageal cancer or other neoplasms. The safety and efficacy of nivolumab in the treatment of H. pylori-associated gastritis and peptic ulcer disease are currently being evaluated in two double-blind Phase III studies with over 12,000 participants. Additional clinical studies are ongoing to establish whether the antibody may be useful in treating gastroesophageal cancers (http://clinicaltrials." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nivolumab?

"We summarize the most common side effects of Nivolumab in patients with advanced or metastatic colorectal cancer, lung cancer, and renal cell carcinoma. The side effects are similar to those observed with any antibody, and all side effects appear to be related to inhibition of PD1. The most common side effects are fatigue, decreased appetite, nausea, abdominal pain, diarrhoea, rash, itch, low blood cell count, and constipation." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for microsatellite instability?

"Most women with MSI-H gastro-oesophageal cancers have a shortened overall survival, whereas some with MSI-L may have an expected long-term survival rate similar to that for women without MSI." - Anonymous Online Contributor

Unverified Answer

Does nivolumab improve quality of life for those with microsatellite instability?

"Treatment with nivolumab was associated with significant improvement in the quality of life of patients with MSI, including an improvement in patient reported pain scores." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nivolumab?

"There are currently two ongoing clinical trials for nivolumab; NCT01574463 and NCT02154816. These trials are not related to each other and enrollment into both trials is open to everyone with advanced metastatic cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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