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Checkpoint Inhibitor
Camu Camu + ICI for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Bertrand Routy, MD, PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-2
Ability to ingest capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 and 6 months, then at 12 months and up to 2 years
Awards & highlights
Study Summary
This trial is testing whether a compound called Camu Camu, which is found in berries, can improve the efficacy of a cancer treatment called immune-checkpoint inhibitors. The trial's primary objective is to assess the safety and tolerability of Camu Camu in patients with advanced NSCLC and melanoma.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) or melanoma, who are receiving standard immune checkpoint inhibitors (ICIs). Participants must not have had prior anti-PD1 treatments (except specific melanoma patients), be able to swallow capsules, and use effective contraception. Exclusions include recent probiotic/prebiotic use, severe immunodeficiency, active infections requiring systemic therapy, certain autoimmune diseases, and pregnancy.Check my eligibility
What is being tested?
The study tests the safety and tolerability of Camu Camu (CC) prebiotic capsules in combination with standard ICIs in treating NSCLC and melanoma. CC may enrich beneficial gut bacteria linked to better ICI response. Patients are grouped based on their disease stage and treatment regimen.See study design
What are the potential side effects?
Potential side effects might relate to the body's reaction to a new substance affecting the gut microbiome but specifics aren't provided. Standard ICI-related side effects can include fatigue, skin reactions, inflammation of organs like lungs or intestines, hormonal changes or flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I can swallow pills.
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I am not pregnant.
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I have advanced melanoma and will be treated with anti-PD-1 therapy.
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I am 18 years old or older.
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I have stage IV or inoperable NSCLC with PD-L1 expression under 50% and will be treated with anti-PD-1 and chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 and 6 months, then at 12 months and up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 6 months, then at 12 months and up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related adverse events (safety and tolerability) in patients with NSCLC and melanoma
Secondary outcome measures
Objective response rate in the NSCLC and melanoma cohort by RECIST criteria.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Camu-camu (intervention) in addition to standard-of-care ICIExperimental Treatment1 Intervention
Camu-camu (intervention) will be added to standard-of-care ICI in:
Cohort 1. For patients with advanced NSCLC, treatment will consist of single-agent pembrolizumab in combination with physician's choice platinum-doublet chemotherapy in combination with CC.
Cohort 2. For patients with advanced cutaneous melanoma, treatment will consist of single-agent anti-PD-1 either nivolumab or pembrolizumab at the discretion of the treating physician.
Cohort 3. For patients with advanced melanoma receiving standard-of-care ICI (either single-agent anti-PD-1 or combination anti-CTLA-4 plus anti-PD-1) who experience progressive disease (PD), their current regimen will continue unchanged and they will receive CC at 1500 mg for 3 months or until confirmed progression if progression occurs earlier.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,592 Total Patients Enrolled
Bertrand Routy, MD, PhDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for an autoimmune disease that is not under control.I am currently being treated for an infection.I have not received anti-PD1 treatment before, unless I am in cohort 3.I have only received the flu shot and COVID-19 vaccines, not the nasal spray flu vaccine.I have been treated with BRAF-targeting drugs before.I have been treated for cancer other than my current diagnosis in the past year.I can take care of myself and perform daily activities.I can swallow pills.You have a disease that can be measured and evaluated using specific medical guidelines.I am not pregnant.I do not have serious heart problems or active inflammatory bowel disorders.I have stopped taking prebiotics 2 weeks before starting treatment and won't take them during treatment.I have stopped taking probiotics 2 weeks before starting treatment and won't take them during treatment.I have a severe immune system issue or am on high-dose steroids or other immune-weakening medicines.I have advanced melanoma and will be treated with anti-PD-1 therapy.I have advanced melanoma and started immunotherapy at the first sign of cancer progression.I have HIV, but it's well-controlled with medication and my viral load is undetectable.I have not taken antibiotics in the last 2 weeks.I have melanoma, but the original tumor location is unknown.I have not received a live vaccine in the last 4 weeks.I can continue in the study even if I need antibiotics during treatment.I am 18 years old or older.I don't expect to need any cancer treatment other than what's in the study.My cancer has spread to the lining of my brain and spinal cord.I am using or willing to use highly effective birth control during and for 60 days after the study.I have had pneumonitis treated with steroids or have it now.You can join the study if you have vitiligo, type I diabetes, well-controlled hypothyroidism from Hashimoto disease, or childhood asthma/allergies that have gone away.Your diagnosis has been confirmed through tissue examination.I am taking no more than 10 mg of prednisone daily or its equivalent.I have symptoms from cancer spread to my brain.I do not have severe kidney, liver disease, or blood test issues that would make chemotherapy unsafe.You have a severe allergy to the study drug, as decided by the sponsor.I have stage IV or inoperable NSCLC with PD-L1 expression under 50% and will be treated with anti-PD-1 and chemotherapy.I have melanoma, but the original tumor location is unknown.
Research Study Groups:
This trial has the following groups:- Group 1: Camu-camu (intervention) in addition to standard-of-care ICI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively recruiting participants?
"According to clinicaltrials.gov, this research is currently recruiting participants for the trial which was first launched on June 29th 2022 and has since been amended with new information as of November 11th 2022."
Answered by AI
Are Camu Camu Capsules (Camu Camu powder encapsulated (500mg each) + ICI an effective and safe treatment for patients?
"Our team at Power believes Camu Camu Capsules is relatively safe and gave it a score of 1 on our scale from 1 to 3, as this trial is still in Phase 1 with limited data supporting safety and efficacy."
Answered by AI
How many volunteers are currently enrolled in this clinical experiment?
"Affirmative. Information found on clinicaltrials.gov elucidates that this research project, which was initially posted on June 29th 2022, is actively recruiting individuals for participation. 45 subjects are sought after from 1 medical centre."
Answered by AI
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