Nivolumab for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Nivolumab

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a cancer treatment called nivolumab (also known as Opdivo) when administered at home compared to in a clinic. Nivolumab is typically administered in hospitals, but the study seeks to determine if home administration can ease the process and enhance the quality of life for cancer patients. Individuals with certain types of cancer, such as melanoma or lung cancer, who are currently receiving or planning to receive nivolumab, may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational or standard treatments for your cancer that are not part of the eligible treatment regimen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that patients generally tolerate nivolumab well. However, like many treatments, it can cause side effects. A small percentage of patients have experienced serious reactions, such as urinary tract infections and kidney problems.

Research indicates that nivolumab can sometimes cause the immune system to mistakenly attack normal organs and tissues, leading to various side effects. Although some side effects can be serious, they are uncommon.

Overall, researchers have studied nivolumab in many patients with different types of cancer, and its safety is well-documented. Discuss any concerns with a healthcare provider, who can help weigh the potential benefits and risks based on individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Nivolumab is unique because it offers an innovative approach to cancer treatment by enhancing the body's immune response to target and destroy cancer cells. Unlike traditional chemotherapy, which directly attacks cancer cells but can also harm healthy cells, nivolumab is a type of immunotherapy. It works by blocking a protein called PD-1, which helps keep immune cells from attacking cancer. This allows the immune system to better identify and fight cancer cells. Researchers are excited about this treatment because it can be administered both in-clinic and at home, making it more convenient for patients and potentially maintaining quality of life while fighting cancer.

What evidence suggests that this trial's treatments could be effective for cancer?

Studies have shown that nivolumab, which participants in this trial will receive, effectively treats several types of cancer. Specifically, research indicates that patients with advanced melanoma who received nivolumab, along with another drug, lived for a median of 72.1 months, highlighting its long-term benefits. In non-small cell lung cancer (NSCLC), real-world data confirmed that nivolumab helps patients who have already received other treatments, supporting its effectiveness in everyday practice. Overall, various studies have demonstrated significant survival benefits for cancer patients using nivolumab. ^{6 7 8 9 10}

Who Is on the Research Team?

Roxana S. Dronca, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with various cancers, including kidney, skin, lung, and others. It's designed for those who may benefit from receiving treatment at home due to difficulties traveling to medical facilities or a preference for the comfort of their own environment.

Inclusion Criteria

My cancer type is approved for nivolumab treatment by the FDA.

I am willing to switch to injections for my treatment.

I am moving to nivolumab alone after finishing treatment with both Ipilimumab and nivolumab.

Exclusion Criteria

I have not received any live vaccines in the last 30 days.

HIV positive with AIDS defining opportunistic infection within the last year or CD4 count < 350 cells/uL unless meeting specific criteria

History of allergy or hypersensitivity to study drug components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-Clinic Treatment

Participants receive nivolumab SC in clinic for 2 cycles, each cycle lasting 28 days

8 weeks

2 visits (in-person)

In-Home Treatment

Participants receive nivolumab SC at home by a home health nursing provider for 4 cycles, each cycle lasting 28 days

16 weeks

4 visits (in-home)

Extended Treatment

Participants continue nivolumab SC administration either in-clinic or at-home for up to 1 year in the absence of disease progression or unacceptable toxicity

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 1 year

Follow-up at days 30 and 100, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab

Trial Overview The study compares subcutaneous Nivolumab administration at home versus in a clinic setting. The focus is on how this affects cancer care quality and patient quality of life. It's a phase II trial that explores whether home treatment can be as safe and effective as clinic-based care.

How Is the Trial Designed?

Group I: Health services research (in-clinic and at-home nivolumab) Experimental Treatment 4 Interventions

Patients receive nivolumab SC on day 1 of each cycle. Cycles repeat every 28 days in clinic for 2 cycles, then at home by a HHNP for 4 cycles, followed by either in-clinic or at-home administration for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive in-home visits by a home health nurse and undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout the study.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Nivolumab, an immune checkpoint inhibitor, significantly improves overall survival and progression-free survival in patients with advanced stage squamous cell non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CHECKMATE 017 study.

The safety and tolerability of nivolumab are favorable, and interestingly, the expression of the PD-L1 ligand does not predict treatment outcomes, suggesting that other factors may influence the effectiveness of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. Lim, JS., Soo, RA.[2018]

Nivolumab (Opdivo) significantly improves overall survival and response rates in previously-treated patients with advanced nonsquamous non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CheckMate 057 trial.

Nivolumab has a manageable adverse event profile and is better tolerated than docetaxel, making it a valuable treatment option for patients who have progressed after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. Keating, GM.[2018]

In a study of 79 pre-treated patients with advanced non-small cell lung cancer, nivolumab significantly prolonged progression-free survival, especially in patients who had a partial response to prior treatments.

The occurrence of skin rash during nivolumab treatment was associated with improved long-term survival, suggesting that this side effect may indicate a favorable response to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Pleiotropic Effects of Nivolumab in Pretreated Advanced or Recurrent Non-small Cell Lung Cancer Cases. Akano, Y., Kuribayashi, K., Funaguchi, N., et al.[2020]

In a study of 45 patients with metastatic melanoma treated with the combination of nivolumab and ipilimumab, the disease control rate was 54% and the objective response rate was 29%, indicating moderate efficacy in a real-world setting.

The treatment had a high toxicity profile, with 88% of patients experiencing adverse events, and 44% discontinuing treatment due to these events, highlighting the need for careful monitoring and management of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy and toxicity of combined nivolumab and ipilimumab in patients with metastatic melanoma. Parakh, S., Randhawa, M., Nguyen, B., et al.[2019]

Nivolumab, an anti-PD-1 antibody, was administered to a 63-year-old female patient with metastatic melanoma after renal transplantation, highlighting the potential for anti-tumor activity in high-risk patients, despite the challenges of concurrent immunosuppression.

The patient experienced acute renal allograft rejection and renal failure shortly after starting nivolumab, indicating significant risks associated with this treatment in transplant recipients, but she later showed a positive clinical response after re-challenging with nivolumab while on hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. Ong, M., Ibrahim, AM., Bourassa-Blanchette, S., et al.[2023]

Nivolumab, an immune checkpoint inhibitor, significantly improved overall survival and progression-free survival compared to docetaxel in patients with advanced squamous non-small cell lung cancer (NSCLC) in the CheckMate 017 trial.

Nivolumab was better tolerated than docetaxel, with manageable adverse effects, making it a promising treatment option for patients who have already undergone chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review in advanced squamous non-small cell lung cancer. Keating, GM.[2022]

In a meta-analysis of five studies involving 2399 patients, nivolumab was found to significantly lower the risk of hematological toxicities such as anemia, neutropenia, and leukopenia compared to other treatments.

The relative risks for these conditions were notably low, indicating that nivolumab may be a safer option regarding hematological side effects, which is important for clinicians when considering treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risks of hematological toxicities of nivolumab in cancer patients: A PRISMA-compliant meta-analysis. Shi, Z., Liu, X., Chen, M., et al.[2023]

Combining nivolumab and ipilimumab shows improved effectiveness in treating metastatic melanoma compared to using either drug alone, based on a retrospective analysis of approximately 7700 patients.

The combination therapy presents a safety profile that includes immune-related adverse events from both drugs, indicating that while the combination is effective, it also carries a heightened risk of toxicity that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. Soldatos, TG., Dimitrakopoulou-Strauss, A., Larribere, L., et al.[2022]

Nivolumab, a PD-1 receptor inhibitor, shows an objective response rate of 18% and a 1-year overall survival rate of 45% in patients with advanced non-small-cell lung cancer, based on a meta-analysis of 20 studies involving 3404 patients.

The presence of PD-L1 expression in patients is associated with a better response to nivolumab, indicating that PD-L1 status can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefit and risk of nivolumab in non-small-cell lung cancer: a single-arm meta-analysis of noncomparative clinical studies and randomized controlled trials. Zhao, B., Zhang, W., Yu, D., et al.[2019]

Nivolumab and pembrolizumab are FDA-approved monoclonal antibodies that target PD-1, helping to enhance T cell activity against cancer by blocking the PD-1/PD-L1 interaction, which allows cancer cells to escape immune detection.

Both drugs have shown efficacy across multiple cancer types, including melanoma and non-small cell lung cancer, and are considered interchangeable options for treating these conditions, which may help manage the rising costs of cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable. Prasad, V., Kaestner, V.[2022]

Nivolumab, a monoclonal antibody targeting the programmed death receptor-1, has shown promising efficacy in treating advanced malignant melanoma, with nearly 25% of patients achieving a partial tumor response in a phase II trial involving previously treated stage III/IV patients.

The treatment demonstrated a durable clinical benefit, with a median progression-free survival of 172 days and an acceptable safety profile, as less than 18% of patients experienced severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review of its use in patients with malignant melanoma. Deeks, ED.[2021]

Nivolumab, an immune checkpoint inhibitor for metastatic melanoma, can cause immune-related adverse events (irAEs) such as colitis, which were observed in two patients after treatment.

The development of these irAEs is linked to a Th1 dominant immune response, and serum levels of C-reactive protein (CRP) and interleukin-6 (IL-6) may serve as potential biomarkers to monitor and manage these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe colitis after PD-1 blockade with nivolumab in advanced melanoma patients: potential role of Th1-dominant immune response in immune-related adverse events: two case reports. Yoshino, K., Nakayama, T., Ito, A., et al.[2020]

Citations

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Efficacy Information | OPDIVO® (nivolumab) In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, ...

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Clinical Trial Results Select your cancer type above to see how OPDIVO, alone or in combination with other therapies, performed in clinical trials.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049060/

Systematic Review on the Effectiveness and Outcomes of ... With a median follow-up time of 19.2 months, the median overall survival (OS) was reported at 21.9 months, and the 12-month PFS rate was 26.3%, ...

4. news.bms.com news.bms.com/news/details/2021/Six-and-a-Half-Year-Outcomes-for-Opdivo-nivolumab-in-Combination-with-Yervoy-ipilimumab-Continue-to-Demonstrate-Durable-Long-Term-Survival-Benefits-in-Patients-with-Advanced-Melanoma/default.aspx

Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in ... With a minimum follow-up of 6.5 years, median overall survival (OS) was 72.1 months with Opdivo plus Yervoy (95% CI: 38.2-NR), the longest ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S152573042030231X

Real-World Effectiveness of Nivolumab Monotherapy After ... This study confirmed the effectiveness of nivolumab monotherapy for previously treated advanced NSCLC in real-world clinical practice.

6. opdivohcp.com opdivohcp.com/safety

Safety Information | OPDIVO® (nivolumab) The most frequent serious adverse reactions reporting in ≥2% of patients who received OPDIVO with chemotherapy were urinary tract infection (4.9%), acute kidney ...

7. accc-cancer.org accc-cancer.org/docs/mediaroom/mediaroom/pdf/opdivo-bms-fact-sheet-3-5-15

Product Fact Sheet for OPDIVO® (nivolumab) The safety of OPDIVO was evaluated in Trial 1, a randomized, open-label trial in which. 370 patients with unresectable or metastatic melanoma received OPDIVO 3 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11196337/

Safety of nivolumab monotherapy in five cancer types This is the largest study examining the safety of nivolumab-treated patients in real-world clinical practice including rare but potentially serious TRAEs.

9. opdivo.com opdivo.com/side-effects

What you should know about side effects OPDIVO and OPDIVO Qvantig can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

10. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1605958/full

The real-world safety of Nivolumab: a pharmacovigilance ... Furthermore, this trial demonstrated superior 5-year overall survival rates for combination therapy (52%) and nivolumab monotherapy (44%) ...