Nivolumab Safety for Cancer
Recruiting in Palo Alto (17 mi)
+517 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Bristol-Myers Squibb
Disqualifiers: No clinical benefit, Adverse events, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Nivolumab (Opdivo) for cancer treatment?
Is Nivolumab safe for humans?
Nivolumab, also known as Opdivo, is generally considered safe but can cause immune-related side effects, such as inflammation in various organs, and rare but serious blood-related issues. It has been associated with diabetic ketoacidosis (a serious diabetes complication) and other immune reactions, especially when combined with other drugs like ipilimumab.678910
How does the drug nivolumab differ from other cancer treatments?
Nivolumab is unique because it is an immune checkpoint inhibitor that targets the PD-1 pathway, helping the immune system recognize and attack cancer cells. Unlike traditional chemotherapy, it is administered intravenously and has a different side effect profile, often being better tolerated.511121314
Eligibility Criteria
This trial is for cancer patients who have previously been treated with Nivolumab, either completed the treatment, experienced progression during it, or stopped due to side effects. They can join for long-term safety follow-up but not receive further Nivolumab unless deemed beneficial by the original study criteria.Inclusion Criteria
I have not completed, progressed on, or stopped nivolumab due to side effects.
I am eligible for nivolumab treatment according to my doctor or the main study.
I have finished or am in the follow-up phase of a previous study.
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Exclusion Criteria
Participants in survival follow-up have no exclusion criteria.
Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive various experimental cancer therapies including Nivolumab monotherapy and combinations with other drugs
Long-term
Follow-up
Participants are monitored for long-term safety and effectiveness of the treatments
6 months
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Indefinite
Treatment Details
Interventions
- Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe main focus of this rollover study is to monitor the long-term safety of Nivolumab in participants who are currently receiving or have received it as part of an earlier 'Parent Study'. It involves observing these patients over time.
Participant Groups
32Treatment groups
Experimental Treatment
Group I: E9: Cabozantinib MonotherapyExperimental Treatment1 Intervention
Group II: E8: Capecitabine MonotherapyExperimental Treatment1 Intervention
Group III: E7: Rucaparib MonotherapyExperimental Treatment1 Intervention
Group IV: E6: Sunitinib MonotherapyExperimental Treatment1 Intervention
Group V: E5: Enzalutamide MonotherapyExperimental Treatment1 Intervention
Group VI: E4: Leucovorin + Oxaliplatin + FluorouracilExperimental Treatment3 Interventions
Group VII: E3: Leucovorin + FluorouracilExperimental Treatment1 Intervention
Group VIII: E2: Regorafinib MonotherapyExperimental Treatment1 Intervention
Group IX: E1: Bevacizumab MonotherapyExperimental Treatment1 Intervention
Group X: E11: Pembrolizumab MonotherapyExperimental Treatment1 Intervention
Group XI: E10: Pemetrexed MonotherapyExperimental Treatment1 Intervention
Group XII: D4: Nivolumab + BevacizumabExperimental Treatment1 Intervention
Group XIII: D3: Nivolumab + DaratumumabExperimental Treatment2 Interventions
Group XIV: D2: Nivolumab + RucaparibExperimental Treatment2 Interventions
Group XV: D1: Nivolumab + TemozolomideExperimental Treatment2 Interventions
Group XVI: C9: Relatlimab + Nivolumab SAV + BevacizumabExperimental Treatment3 Interventions
Group XVII: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1Experimental Treatment2 Interventions
Group XVIII: C7: Relatlimab + Nivolumab SAV Dose 3Experimental Treatment2 Interventions
Group XIX: C6: Relatlimab + Nivolumab + CapecitabineExperimental Treatment2 Interventions
Group XX: C5: Relatlimab + Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXI: C4: Relatlimab + Nivolumab SAV Dose 2Experimental Treatment2 Interventions
Group XXII: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2Experimental Treatment1 Intervention
Group XXIII: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1Experimental Treatment2 Interventions
Group XXIV: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1Experimental Treatment1 Intervention
Group XXV: C12: Relatlimab + Nivolumab SAV Dose 5Experimental Treatment2 Interventions
Group XXVI: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2Experimental Treatment2 Interventions
Group XXVII: C10: Relatlimab + Nivolumab SAV Dose 4Experimental Treatment2 Interventions
Group XXVIII: B3: Nivolumab + Ipilimumab + TrametinibExperimental Treatment3 Interventions
Group XXIX: B2: Nivolumab + Ipilimumab + CabozantinibExperimental Treatment3 Interventions
Group XXX: B1: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group XXXI: A2: Nivolumab Monotherapy Dose 2Experimental Treatment1 Intervention
Group XXXII: A1: Nivolumab Monotherapy Dose 1Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
Levine Cancer CenterCharlotte, NC
Local Institution - 0168Oshawa, Canada
Charleston OncologyCharleston, SC
More Trial Locations
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Who Is Running the Clinical Trial?
Bristol-Myers SquibbLead Sponsor
Janssen PharmaceuticalsIndustry Sponsor
NovartisIndustry Sponsor
ExelixisIndustry Sponsor
Clovis Oncology, Inc.Industry Sponsor
References
Serious Immune-related Adverse Events Are Associated With Greater Efficacy of Nivolumab Therapy Against Non-small Cell Lung Cancer. [2023]The aim of this study was to investigate possible association between adverse events of nivolumab therapy and the effectiveness of treatment in patients with non-small cell lung cancer (NSCLC). Focusing on serious adverse events (i.e., those of grade ≥3), we evaluated overall survival (OS), progression-free survival (PFS), as well as objective response rate (ORR) to treatment.
Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. [2019]Nivolumab, a programmed death-1 inhibitor, prolonged overall survival and had a favourable safety profile versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) in the phase III CheckMate 057 trial.
Activity of Nivolumab and Utility of Neutrophil-to-Lymphocyte Ratio as a Predictive Biomarker for Advanced Non-Small-Cell Lung Cancer: A Prospective Observational Study. [2022]The immune checkpoint inhibitor nivolumab is entering routine oncologic practice. We investigated the safety and efficacy of nivolumab in the real world and alternative predictive factors for survival in patients with advanced non-small-cell lung cancer (NSCLC).
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
Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. [2018]Progress in the treatment of patients with advanced stage squamous cell non-small cell lung cancer (NSCLC) has been limited. An improvement in the understanding of tumor immunosurveillance has resulted in the development of the immune checkpoint inhibitors such as nivolumab. Nivolumab (Opdivo(®)), a human immunoglobulin (Ig)G4 anti-programmed death (PD)-1 monoclonal antibody, was the first PD-1 inhibitor approved in the treatment of patients with advanced stage squamous cell NSCLC following platinum-based chemotherapy. CHECKMATE 017, a randomized phase III study of second-line nivolumab versus docetaxel, significantly improved overall survival (OS), progression-free survival (PFS), patient reported outcomes and the safety and tolerability favored patients treated with nivolumab. The ligand (PD-L1) expression did not predict for outcome. In this paper, we review the role of nivolumab in the treatment of NSCLC with particular attention on recent studies, ongoing combination studies, toxicity profile, current and potential predictive biomarkers.
Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]Nivolumab and pembrolizumab are antibodies against the programmed-death-receptor- 1 (PD-1) which are associated with distinct immune related adverse effects (AEs). This meta-analysis of randomized clinical trials aims to summarize current knowledge regarding the toxicity profile of these agents.
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]Recent studies suggest that combining nivolumab with ipilimumab is a more effective treatment for melanoma patients, compared to using ipilimumab or nivolumab alone. However, treatment with these immunotherapeutic agents is frequently associated with increased risk of toxicity, and (auto-) immune-related adverse events. The precise pathophysiologic mechanisms of these events are not yet clear, and evidence from clinical trials and translational studies remains limited. Our retrospective analysis of ~7700 metastatic melanoma patients treated with ipilimumab and/or nivolumab from the FDA Adverse Event Reporting System (FAERS) demonstrates that the identified immune-related reactions are specific to ipilimumab and/or nivolumab, and that when the two agents are administered together, their safety profile combines reactions from each drug alone. While more prospective studies are needed to characterize the safety of ipilimumab and nivolumab, the present work constitutes perhaps the first effort to examine the safety of these drugs and their combination based on computational evidence from real world post marketing data.
The risks of hematological toxicities of nivolumab in cancer patients: A PRISMA-compliant meta-analysis. [2023]Nivolumab is the human programmed cell death-1 (PD-1)-blocking antibody showing significant effect in many refractory cancers. However, little is known about its risks of hematological toxicities, rare but clinically serious and potentially life-threatening adverse events. We want to explore whether nivolumab can increase the risks of hematological toxicities compared with other immunotherapy or chemotherapy drugs.
Real-world efficacy and toxicity of combined nivolumab and ipilimumab in patients with metastatic melanoma. [2019]There is limited real-world data on the efficacy and safety of combination programmed cell death protein-1 (PD-1) inhibitor, nivolumab and the cytotoxic T-lymphocyte antigen (CTLA-4) inhibitor ipilimumab.
Diabetic ketoacidosis induced by nivolumab in invasive mucinous adenocarcinoma of the lung: a case report and review of the literature. [2022]Nivolumab is the first programmed cell death receptor 1 (PD-1) inhibitor approved in China. Compared with chemotherapy, nivolumab has shown advantages of good efficacy and safety in the treatment of a variety of tumors. However, due to its short time of use in China and lack of safety experience, clinical understanding of its adverse reactions has not been sufficiently elucidated. In recent years, cases of diabetic ketoacidosis caused by nivolumab have been reported in the emergency department, which has aroused our concern.
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]Nivolumab (Opdivo™) is a novel IgG4 subclass programmed death-1 (PD-1) inhibiting antibody that has demonstrated breakthrough-designation anti-tumor activity. To date, clinical trials of nivolumab and other checkpoint inhibitors have generally excluded patients with solid organ transplantation and patients with concurrent immunosuppression. However, organ transplant recipients are at high-risk of development of malignancy as a result of suppressed immune surveillance of cancer.
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]The programmed death (PD)-1 immune checkpoint inhibitor nivolumab (Opdivo(®)) is approved in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progression on or after platinum-based chemotherapy and in the EU for the treatment of adults with locally advanced or metastatic NSCLC after prior chemotherapy. In previously-treated patients with advanced nonsquamous NSCLC, overall survival was significantly prolonged and the overall response rate was significantly higher in patients who received intravenous nivolumab 3 mg/kg every 2 weeks versus intravenous docetaxel in the pivotal CheckMate 057 trial. Progression-free survival did not significantly differ between patients receiving nivolumab and those receiving docetaxel. Intravenous nivolumab had a manageable adverse event profile (including immune-mediated adverse events) and was better tolerated than docetaxel in the CheckMate 057 trial. Thus, nivolumab is an important new option for use in previously-treated patients with advanced nonsquamous NSCLC.
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]Nivolumab (Opdivo(®); Nivolumab BMS™) was the first programmed death (PD)-1 immune checkpoint inhibitor to be approved for use in advanced, squamous non-small cell lung cancer (NSCLC) following prior chemotherapy. In the pivotal CheckMate 017 trial, intravenous nivolumab 3 mg/kg every 2 weeks was associated with significantly better overall survival and progression-free survival and a significantly higher overall response rate than intravenous docetaxel in the second-line treatment of advanced, squamous NSCLC. Nivolumab was also better tolerated than docetaxel in CheckMate 017, and its adverse event profile (which included immune-mediated adverse events) was manageable. In conclusion, nivolumab represents an important advance in previously-treated, advanced, squamous NSCLC.
Analysis of Pleiotropic Effects of Nivolumab in Pretreated Advanced or Recurrent Non-small Cell Lung Cancer Cases. [2020]Nivolumab is an immune checkpoint inhibitor for advanced non-small cell lung cancer (NSCLC). We investigated the safety and efficacy of nivolumab by analyzing the response factor, adverse effects (AE), and the post-treatment condition of pretreated advanced or recurrent NSCLC patients.