Immune Checkpoint Inhibitors for Cancer
(DiRECT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how immune checkpoint inhibitors, a type of cancer treatment, work in patients of different racial backgrounds, specifically African American/Black and European American/White. Researchers will collect blood, saliva, and health information to investigate potential healthcare differences. The study seeks participants who identify as African American/Black or European American/White, have invasive cancer, and are scheduled to receive specific immune therapy treatments.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications for this trial?
The trial does not specify whether you need to stop taking your current medications. It focuses on patients already receiving immune checkpoint inhibitor treatment, so you may continue with those treatments.
What is the safety track record for immune checkpoint inhibitors?
Research has shown that immune checkpoint inhibitors, a type of cancer treatment, have been tested for safety in people. In one study, 86% of patients experienced some side effects, while more serious side effects occurred in 56.1% of patients. The FDA has already approved these treatments for certain cancers, indicating they are considered safe enough for those conditions. However, like all medications, they can have risks and side effects. Anyone considering this treatment should discuss the possible risks and benefits with their doctor.12345
Why are researchers excited about this trial?
Researchers are excited about immune checkpoint inhibitors because they offer a fresh approach to cancer treatment by enhancing the body’s immune system to fight cancer cells more effectively. Unlike traditional cancer treatments, which often directly target cancer cells but can damage healthy cells too, immune checkpoint inhibitors work by blocking proteins that prevent the immune system from attacking cancer cells. This mechanism helps the immune system recognize and destroy cancer cells while potentially sparing healthy ones, leading to fewer side effects and improved patient outcomes. Additionally, these inhibitors have shown promise in treating various types of cancer, offering hope for patients who may not respond well to conventional therapies.
What evidence suggests that immune checkpoint inhibitors could be effective for cancer?
Research has shown that immune checkpoint inhibitors are effective for some cancers. Studies have found that using two of these drugs, nivolumab and ipilimumab, together can significantly improve survival rates. For instance, in patients with melanoma, a type of skin cancer, the 10-year survival rate exceeded 96% with this combination. Another study showed that after five years, 52% of patients were still alive when treated with both drugs, compared to only 26% with ipilimumab alone. These treatments help the immune system find and attack cancer cells, offering hope for those with advanced cancers. Note that this trial is observational and involves questionnaires, biospecimen collection, and medical record reviews, rather than direct treatment with these drugs.678910
Who Is on the Research Team?
Charles Kamen, PhD
Principal Investigator
University of Rochester NCORP Research Base
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive immune checkpoint inhibitor treatment and undergo collection of blood, saliva, and optional stool samples before 1st and 2nd infusion of immunotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including additional questionnaires and blood sample collections every year after the 1st infusion
What Are the Treatments Tested in This Trial?
Interventions
- Immune Checkpoint Inhibitors
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
Immune Checkpoint Inhibitors is already approved in European Union, United States for the following indications:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Squamous cell carcinoma of the head and neck
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Squamous cell carcinoma of the head and neck
- Melanoma
- Melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester NCORP Research Base
Lead Sponsor
Roswell Park Cancer Institute
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in ...
Among patients who had been alive and progression-free at 3 years, 10-year melanoma-specific survival was 96% with nivolumab plus ipilimumab, 97 ...
Pooled Long-Term Outcomes With Nivolumab Plus ...
Baseline characteristics and efficacy data were pooled across the six studies. OS and melanoma-specific survival (MSS) rates at fixed time ...
Five-Year Survival with Combined Nivolumab and ...
Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group.
Comparative efficacy of combined CTLA-4 and PD-1 ...
Our real-world data indicate that combined CTLA-4 and PD-1 blockade is most beneficial for patients with multi-organ metastasis.
Real-World Outcomes of Ipilimumab–Nivolumab vs. Anti- ...
Emerging evidence from retrospective series and multicenter studies suggests higher response rates with the combination, but at the expense of substantially ...
Real-world efficacy and safety data of nivolumab ...
Adverse events occurred in 86% of patients; 56.1% were grade 3 or worse. The response rate in an actual clinical setting, including the prior systemic therapy ...
Safety data from an expanded access program (EAP) of ...
Background: NIVO (anti-PD-1) and IPI (anti-CTLA-4), alone and in combination, are FDA-approved for the treatment of patients (pts) with MEL.
Preliminary real-world safety data of nivolumab (nivo) ...
We aimed to evaluate the safety of nivolumab + ipilimumab (nivo + ipi) in advanced melanoma patients who had relapsed after ≥1 line of systemic treatment in a ...
Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies ...
Data from a phase I trial combining ipilimumab and nivolumab demonstrated promising results in a cohort of 53 patients: response rates ...
The real-world safety of Nivolumab: a pharmacovigilance ...
To further evaluate the real-world safety of nivolumab, this study analyzed data from the FDA Adverse Event Reporting System (FAERS) database.
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