Camu Camu + ICI for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must be taking: Anti-PD-1, Platinum-doublet
Must not be taking: Probiotics, Prebiotics, Antibiotics
Disqualifiers: Pregnancy, Severe immunodeficiency, CNS metastases, others
No Placebo Group
Breakthrough Therapy
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a natural berry supplement to improve gut health in patients with advanced lung cancer and melanoma. These patients often do not respond well to current treatments. The supplement works by increasing beneficial gut bacteria, potentially making cancer treatments more effective. Berries have shown potential against several cancers, including lung cancer and melanoma, by influencing cellular processes and improving gut health.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop taking probiotics and prebiotics at least 2 weeks before starting, and you cannot take them during the trial. Antibiotics should also be stopped 2 weeks before, but if needed during the trial, you can continue. Other medications are not specifically mentioned, so check with the trial team.
What data supports the effectiveness of the drug Camu Camu + ICI for Non-Small Cell Lung Cancer?
Research shows that combining nivolumab and ipilimumab, which are part of the immune checkpoint inhibitors (drugs that help the immune system fight cancer), can improve survival in patients with advanced non-small cell lung cancer compared to traditional chemotherapy.
12345Is the combination of Camu Camu and immune checkpoint inhibitors safe for humans?
Immune checkpoint inhibitors like nivolumab and ipilimumab can cause serious side effects, including heart problems and immune-related reactions affecting the skin, liver, and lungs. While these side effects are rare, they should be monitored closely. There is no specific safety data available for Camu Camu in combination with these drugs.
678910How is the Camu Camu + ICI treatment different from other drugs for non-small cell lung cancer?
The Camu Camu + ICI treatment is unique because it combines natural ingredients from Camu Camu with immune checkpoint inhibitors (drugs that help the immune system attack cancer cells), which may offer a novel approach compared to traditional chemotherapy or ICI alone.
411121314Eligibility Criteria
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.Inclusion Criteria
I have not received anti-PD1 treatment before, unless I am in cohort 3.
I have been treated with BRAF-targeting drugs before.
I can take care of myself and perform daily activities.
+13 more
Exclusion Criteria
I am taking medication for an autoimmune disease that is not under control.
I am currently being treated for an infection.
I have only received the flu shot and COVID-19 vaccines, not the nasal spray flu vaccine.
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Camu Camu prebiotic in combination with standard-of-care immune checkpoint inhibitors
3 months
Every 21 or 28 days, depending on ICI treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Every 3 months
Participant Groups
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.
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.
Immune Checkpoint Inhibitors is already approved in European Union, United States, European Union, United States for the following indications:
🇪🇺 Approved in European Union as Nivolumab for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Squamous cell carcinoma of the head and neck
🇺🇸 Approved in United States as Nivolumab for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Squamous cell carcinoma of the head and neck
🇪🇺 Approved in European Union as Ipilimumab for:
- Melanoma
🇺🇸 Approved in United States as Ipilimumab for:
- Melanoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jewish General HospitalMontreal, Canada
CISSS de la Montérégie-Centre- Hôpital Charles-Le MoyneLongueuil, Canada
Centre hospitalier de l'Université de Montréal (CHUM)Montréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis. [2023]First-line nivolumab plus ipilimumab prolongs survival versus chemotherapy in advanced non-small-cell lung cancer (NSCLC). We further characterized clinical benefit with this regimen in a large pooled patient population and assessed the effect of response on survival.
Impact of clinicopathological features on the efficacy of immune checkpoint inhibitors plus conventional treatment in patients with advanced lung cancer. [2022]To investigate the impact of different immune checkpoint inhibitors (ICI), programmed-death ligand 1 (PD-L1) expression and clinical characteristics on clinical outcome of ICI plus conventional treatment in advanced lung cancer patients.
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. [2022]Nivolumab plus ipilimumab demonstrated clinically meaningful improvement in efficacy versus chemotherapy with a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% or
Cox Proportional Hazard Ratios Overestimate Survival Benefit of Immune Checkpoint Inhibitors: Cox-TEL Adjustment and Meta-Analyses of Programmed Death-Ligand 1 Expression and Immune Checkpoint Inhibitor Survival Benefit. [2023]Survival benefit of immune checkpoint inhibitor (ICI) therapy in lung cancer is not fully understood.
Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. [2022]Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer.
Prognostic and predictive factors associated with ipilimumab-related adverse events: a retrospective analysis of 11 NCI-sponsored phase I clinical trials. [2023]We review factors impacting ipilimumab-associated adverse events through the experience from National Cancer Institute (NCI)-sponsored phase I immunotherapy clinical trials.
Immune Checkpoint Inhibitors and Immune-Related Adverse Drug Reactions: Data From Italian Pharmacovigilance Database. [2022]The introduction of immune checkpoint inhibitors (ICIs) in clinical practice has brought significant benefits for patients. Seven ICIs are available in Europe: nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, and ipilimumab. Despite their proven clinical efficacy, these innovative drugs may cause serious immune-related adverse drugs reactions (irADRs). Given the significance of these ADRs for patients' health, we analyzed individual case safety reports (ICSRs) related to ICIs, focusing on those reporting irADRs, collected in the Italian spontaneous reporting database.
Immunotherapy-associated complete heart block in a patient with NSCLC: A case report and literature review. [2021]The role for PD-1/PD-L1 and CTLA-4 targeted immunotherapy is well outlined in the treatment of metastatic NSCLC. Increased survival benefit supports the use of these medications and the development of next-generation agents with improved efficacy and favorable side-effect profiles. The prevalence of immunotherapy-associated cardiotoxicity (IAC) has grown significantly over the past two years as awareness of this toxicity class has emerged. High-grade conduction disorders comprise a subset of cardiotoxicities with a high case fatality rate. We presented a case of suspected combination ipilimumab-nivolumab associated 3rd degree heart block. The onset of this event was 16 days after immunotherapy initiation. A literature review has suggested that over 75% of cases of cardiotoxicity are observed within the first 6 weeks. We present findings from an interrogation of the FDA Adverse Event Reporting System (FAERS) and provide clinical guidance for the early identification of high-risk patients.
Comprehensive Meta-analysis of Key Immune-Related Adverse Events from CTLA-4 and PD-1/PD-L1 Inhibitors in Cancer Patients. [2023]Immune-related adverse events (irAE) have been described with immune checkpoint inhibitors (ICI), but the incidence and relative risk (RR) of irAEs associated with these drugs remains unclear. We selected five key irAEs from treatments with approved cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), programmed cell death 1 (PD-1), and programmed death ligand 1 (PD-L1) inhibitors (ipilimumab, nivolumab, or pembrolizumab, and atezolizumab, respectively) to better characterize their safety profile. We performed a meta-analysis of randomized phase II/III immunotherapy trials, with non-ICI control arms, conducted between 1996 and 2016. We calculated the incidence and RR of selected all-grade and high-grade gastrointestinal, liver, skin, endocrine, and pulmonary irAEs across the trials using random-effect models. Twenty-one trials were included, totaling 11,454 patients, of whom 6,528 received an ICI (nivolumab, 1,534; pembrolizumab, 1,522; atezolizumab, 751; and ipilimumab, 2,721) and 4,926 had not. Compared with non-ICI arms, ICIs were associated with more all-grade colitis (RR 7.66, P < 0.001), aspartate aminotransferase (AST) elevation (RR 1.80; P = 0.020), rash (RR 2.50; P = 0.001), hypothyroidism (RR 6.81; P < 0.001), and pneumonitis (RR 4.14; P = 0.012). Rates of high-grade colitis (RR 5.85; P < 0.001) and AST elevation (RR 2.79; P = 0.014) were higher in the ICI arms. Ipilimumab was associated with a higher risk of all-grade rash (P = 0.006) and high-grade colitis (P = 0.021) compared with PD-1/PD-L1 ICIs. Incidence of fatal irAE was < 1%. This meta-analysis offers substantial evidence that ICIs are associated with a small but significant increase in risk of selected all-grade irAEs and high-grade gastrointestinal and liver toxicities. Although fatal irAEs remain rare, AEs should be recognized promptly as early interventions may alleviate future complications. Cancer Immunol Res; 5(4); 312-8. ©2017 AACR.
Predictors of immune-related adverse events and outcomes in patients with NSCLC treated with immune-checkpoint inhibitors. [2022]To identify predictors of immune-related adverse events (IRAEs) in patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICIs). Assess associations between outcomes and the development of IRAEs.
The efficacy and safety of immune checkpoint inhibitor plus chemotherapy in patients with advanced non-small-cell lung cancer: a meta-analysis. [2022]To evaluate the efficacy and safety of immune checkpoint inhibitor (ICI) and chemotherapy (CT) versus CT alone in advanced non-small-cell lung cancer (NSCLC).
Association of tumour and stroma PD-1, PD-L1, CD3, CD4 and CD8 expression with DCB and OS to nivolumab treatment in NSCLC patients pre-treated with chemotherapy. [2021]Immune checkpoint inhibitors are most beneficial in patients with high tumour PD-L1 expression. However, the use of PD-L1 expression is not straightforward. We investigated PD-L1 expression and immune cell (IC) infiltrates in non-small-cell lung cancer (NSCLC) patients treated with nivolumab.
A Randomized Comparison of Nivolumab versus Nivolumab + Docetaxel for Previously Treated Advanced or Recurrent ICI-Naïve Non-Small Cell Lung Cancer: TORG1630. [2023]The addition of cytotoxic chemotherapy to immune-checkpoint inhibitor (ICI) may enhance antitumor effects. We conducted an open-label randomized phase II/III study to evaluate nivolumab + docetaxel combination therapy in comparison with nivolumab monotherapy for previously treated ICI-naïve non-small cell lung cancer (NSCLC).
Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer. [2021]The present study was conducted to evaluate the efficacy and tolerability of using an immune checkpoint inhibitor (ICI; programmed cell death protein 1/ligand 1 [PD-1/PD-L1] inhibitor or cytotoxic T-lymphocyte antigen [CTLA]-4 inhibitor) combined with chemotherapy in the first-line treatment of small cell lung cancer.