Immune Therapy Delivery Methods for Cancer
(PSI-Immune Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether patients and healthcare professionals prefer receiving cancer treatments nivolumab or pembrolizumab (both immune therapies) through subcutaneous injections or IV administration. The goal is to determine which method offers greater convenience and comfort. The trial involves cycles of both methods to compare experiences. It suits individuals with advanced cancers, such as melanoma or lung cancer, who are either new to these treatments or already receiving them. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants can be on certain existing treatments like nivolumab or pembrolizumab, either alone or with other approved drugs. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both under-the-skin and IV forms of nivolumab and pembrolizumab are generally well-tolerated. Studies found that under-the-skin nivolumab has a safety profile similar to the IV form, with serious side effects like heart inflammation occurring in about 1.2% of patients. This is comparable to the IV version, which also showed some serious reactions but in a slightly higher percentage of patients.
Under-the-skin pembrolizumab also demonstrates similar safety to its IV counterpart. One study found that 47% of patients experienced severe side effects when combined with chemotherapy, consistent with the known safety profile of pembrolizumab.
Overall, both under-the-skin and IV methods for these treatments have been tested and show similar safety levels, though serious side effects can occur in some cases.12345Why are researchers excited about this trial's treatments?
Researchers are excited about exploring different delivery methods for immune therapies like nivolumab and pembrolizumab in cancer treatment. Unlike the traditional intravenous (IV) administration, this trial is investigating the potential benefits of delivering these drugs subcutaneously (SC) as well. The SC method could offer greater convenience and comfort for patients, potentially leading to increased adherence and better quality of life. By switching the delivery method during treatment cycles, researchers aim to determine if there are differences in effectiveness or side effects, which could lead to more personalized and flexible treatment options for cancer patients.
What evidence suggests that this trial's treatments could be effective for cancer?
This trial will compare different delivery methods for the cancer treatments nivolumab and pembrolizumab. Research has shown that both subcutaneous (under-the-skin) and intravenous (through-the-vein) forms of these treatments are effective. Participants will receive either subcutaneous nivolumab or pembrolizumab for three cycles followed by intravenous administration for three cycles, or vice versa. Previous studies on nivolumab indicate similar overall response rates: 24.2% for subcutaneous and 18.2% for intravenous. In terms of survival, 72% of patients treated with subcutaneous nivolumab were alive after 12 months, nearly matching the intravenous form. For pembrolizumab, the response rates were nearly identical: 45.4% for subcutaneous and 42.1% for intravenous. Both forms of pembrolizumab also showed similar survival rates. This evidence suggests that the delivery method—whether subcutaneous or intravenous—does not significantly affect the effectiveness of these treatments.36789
Who Is on the Research Team?
Diwakar J Davar, MD
Principal Investigator
UPMC Hillman Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with various cancers, including colon, lung, kidney, esophageal, melanoma, liver and cervical cancer. It's focused on those who are candidates for immune therapy with nivolumab or pembrolizumab.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either SC or IV administration of nivolumab or pembrolizumab for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Pembrolizumab
Trial Overview
The study compares patient and healthcare professional preferences between Subcutaneous (SC) injections and Intravenous (IV) infusions of two immune therapies: nivolumab and pembrolizumab.
How Is the Trial Designed?
2
Treatment groups
Active Control
SC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles.
IV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
Diwakar Davar
Lead Sponsor
Citations
A Single-Center Retrospective Study - PMC
Methods: We reviewed the records of 153 participants with stage IV melanoma who received nivolumab monotherapy between February 2012 and ...
Subcutaneous versus intravenous nivolumab for renal cell ...
After 8 months of minimum follow-up, ORR was 24.2% with subcutaneous nivolumab (95% CI 19.0%-30.0%) versus 18.2% with intravenous nivolumab [95% ...
Five-Year Survival Outcomes With Nivolumab Plus ...
We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy ...
4.
hopkinsmedicine.org
hopkinsmedicine.org/news/newsroom/news-releases/2019/07/favorable-five-year-survival-reported-for-patients-with-advanced-cancer-treated-with-the-immunotherapy-drug-nivolumabFavorable Five-Year Survival Reported For Patients With ...
By comparison, the results with nivolumab, reported July 25 in JAMA Oncology, show higher than expected rates of five-year survival: 34.2% for ...
Clinical Trial Results
Select your cancer type above to see how OPDIVO, alone or in combination with other therapies, performed in clinical trials.
Safety Information | OPDIVO® (nivolumab)
Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with YERVOY; these included pneumonitis, interstitial lung disease, ...
Assessment of nivolumab exposure and clinical safety ...
Nivolumab 480 mg Q4W is predicted to have a similar overall exposure and safety profile to 3 mg/kg Q2W and 240 mg Q2W dosing across patients with various tumor ...
OPDIVO (nivolumab) injection Label - accessdata.fda.gov
In a trial assessing the pharmacokinetics and safety of a more rapid infusion, in which patients received OPDIVO as a 60-minute intravenous infusion or a 30 ...
Product Fact Sheet for OPDIVO® (nivolumab)
Metastatic Squamous Non-Small Cell Lung Cancer. The safety of OPDIVO was evaluated in Trial 3, a single-arm multinational, multicenter trial in 117 patients ...
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