340 Participants Needed

RP1 + Nivolumab for Cancer

(IGNYTE Trial)

Recruiting at 54 trial locations
CT
Overseen ByClinical Trials at Replimune
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic anti-viral medications, you may not be eligible to participate.

What data supports the effectiveness of the drug Nivolumab in treating cancer?

Nivolumab has shown to improve overall survival and response rates in patients with advanced non-small cell lung cancer (NSCLC) compared to traditional chemotherapy, and it is better tolerated with a manageable side effect profile.12345

What is known about the safety of Nivolumab and RP1 in humans?

Nivolumab, used in cancer treatment, has been studied in many trials and is generally safe, but can cause side effects like fatigue, rash, itching, diarrhea, nausea, and weakness. Serious side effects are less common, with low rates of severe low phosphate levels and low white blood cell counts. RP1, also known as vusolimogene oderparepvec, is less well-known, but combining it with Nivolumab is being studied for safety.678910

How is the drug RP1 + Nivolumab unique for cancer treatment?

RP1 + Nivolumab is unique because it combines a virus-based therapy (RP1) with an immune checkpoint inhibitor (Nivolumab), which helps the immune system recognize and attack cancer cells more effectively. This combination aims to enhance the body's natural defenses against cancer, offering a novel approach compared to traditional treatments.24111213

What is the purpose of this trial?

This trial tests a modified virus (RP1) and an immune-boosting drug (nivolumab) in adults with advanced or treatment-resistant solid tumors. RP1 kills cancer cells and helps the immune system recognize them, while nivolumab enhances the immune response. Nivolumab has been approved for treating advanced melanoma, renal cell carcinoma, non-small cell lung cancer, and other malignancies.

Research Team

JH

Jeannie Hou, MD

Principal Investigator

Replimune Inc.

Eligibility Criteria

This trial is for adults with advanced skin cancer, melanoma, Lynch syndrome, or non-small cell lung cancer who have measurable disease and are in good physical condition (ECOG PS 0-1). Participants must have previously failed treatments including anti-PD1/PD-L1 therapy. They should be able to provide a tumor sample and not have a history of certain viral infections or heart diseases.

Inclusion Criteria

You are expected to live for at least 3 more months.
My skin cancer worsened on anti-PD1 treatment for 8+ weeks and I know my BRAF status.
I can provide a sample of my tumor for testing.
See 6 more

Exclusion Criteria

I have been treated with a virus-based cancer therapy before.
I have brain metastasis that is not being treated.
I have had viral infections as outlined in the study protocol.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation phase for single agent RP1 to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

20 weeks

Dose Expansion

Expansion phase with a combination of RP1 and nivolumab to evaluate safety, tolerability, and preliminary efficacy

26 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 months

Treatment Details

Interventions

  • Nivolumab
  • RP1
Trial Overview The study is testing RP1 alone and combined with nivolumab to find the safest dose that works best (MTD/RP2D) against solid tumors. It's an early-phase trial where everyone gets treatment: some just get RP1, others get it with nivolumab.
Participant Groups
10Treatment groups
Experimental Treatment
Group I: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy
Group II: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy
Group III: RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous MelanomaExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy
Group IV: RP1 (IT) and nivolumab (IV) in melanomaExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma
Group V: RP1 (IT) and nivolumab (IV) in NMSCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer
Group VI: RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors
Group VII: Dose expansion of RP1 and nivolumab (IV) in superficial tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial tumors with nivolumab (IV)
Group VIII: Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)
Group IX: Dose escalation of RP1 by intratumoral (IT) injection in superficial tumorsExperimental Treatment1 Intervention
Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
Group X: Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumorsExperimental Treatment1 Intervention
Dose escalation of RP1 alone in 3 cohorts with IT injections in deep/visceral tumors

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Replimune Inc.

Lead Sponsor

Trials
16
Recruited
1,700+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Nivolumab plus ipilimumab showed durable and long-term efficacy in treating advanced non-small cell lung cancer (NSCLC) compared to chemotherapy, regardless of tumor PD-L1 expression levels.
These findings are based on updated results from part 1 of the phase 3 CheckMate 227 trial, indicating that this combination therapy could be a more effective frontline treatment option for NSCLC patients.
Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC.Kahl, KL.[2021]
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.
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.
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer.Keating, GM.[2018]

References

Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC. [2021]
Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. [2018]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Nivolumab for recurrent squamous-cell carcinoma of the head and neck. [2018]
Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]
Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials. [2022]
Association Between Immune-related Adverse Events and Clinical Outcome Following Nivolumab Treatment in Patients With Metastatic Renal Cell Carcinoma. [2021]
Prognostic impact of immune-related adverse events in metastatic renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]
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. [2020]
Pharmacokinetics, pharmacodynamics and clinical efficacy of nivolumab in the treatment of metastatic renal cell carcinoma. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab treatment for advanced renal cell carcinoma: Considerations for clinical practice. [2019]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
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