What side effects are associated with this type of intervention?

Common treatments for solid tumors, especially those enhancing immune response like RP3 combined with anti-PD1 therapy, often lead to immune-related adverse events. These include fatigue, rash, diarrhea, and pruritus. More severe side effects can involve pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, as the immune system may also target normal tissues.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of solid tumors, particularly those that enhance the immune response against cancer. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are immune checkpoint inhibitors targeting the PD-1 pathway. These drugs have shown efficacy in various solid tumors, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, combination therapies such as nivolumab with ipilimumab (Yervoy), which targets CTLA-4, have been approved for enhanced anti-tumor activity. These treatments are similar to the investigational drug RP3, which is being studied for its potential to boost the immune response against solid tumors.

What other types of research exist?

Promising novel alternatives to RP3 for solid tumors include: 1) Nivolumab and Ipilimumab combination therapy, which has shown efficacy in various solid tumors including renal cell carcinoma and mesothelioma. 2) Atezolizumab plus Bevacizumab, particularly for renal cell carcinoma, as demonstrated in the IMmotion151 trial. 3) Pembrolizumab, which has shown activity in mesothelioma and other solid tumors in multiple trials. 4) Cabozantinib, which has been effective after immune checkpoint blockade in renal cell carcinoma. These therapies have demonstrated potential in enhancing immune response and improving clinical outcomes in solid tumor patients.

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RP3 + Nivolumab for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Replimune Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

At least one injectable tumor ≥ 1 cm in longest diameter or injectable tumors which in aggregate are ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes)

Must not have

History of interstitial lung disease

Requires intermittent or chronic use of systemic antivirals

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years since first patient in

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called RP3, which is a modified virus designed to attack cancer cells and help the immune system fight cancer. It targets adult patients with advanced solid tumors who need new treatment options. The virus works by directly killing cancer cells and boosting the body's immune response against the cancer. Reovirus is a double-stranded RNA virus that has shown promise in targeting cancer cells.

Who is the study for?

Adults with advanced solid tumors who've exhausted standard treatments or can't tolerate them, and have at least one measurable tumor. Participants must be in good physical condition (ECOG 0-1), provide tumor biopsy samples, and not have neurological tumors or certain viral infections.

What is being tested?

The study is testing RP3 alone and combined with Nivolumab to find the safest dose for Phase 2 trials. It's an early-stage trial (Phase 1) involving adults with advanced solid tumors to assess safety, tolerability, and optimal dosing.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions related to immune therapies such as fatigue, flu-like symptoms, skin reactions, potential organ inflammation due to immune response, and infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have a tumor that can be injected and is at least 1 cm big.

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I have a tumor that can be injected and is at least 1 cm big.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung scarring or fibrosis.

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I regularly take medication for a viral infection.

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I am currently on IV antibiotics for an infection.

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I have had or currently have lung inflammation treated with steroids.

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I have been treated with a virus-based cancer therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years since first patient in

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years since first patient in

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years since first patient in for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of serious adverse events (SAEs)

Incidence and severity of treatment emergent adverse events (TEAEs)

Incidence of TEAEs ≥ Grade 3

+3 more

Secondary study objectives

Change in HSV-1 antibody levels

Incidence of clearance of RP3 from blood and urine

Median duration of response

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Seronegative cohortExperimental Treatment1 Intervention

Doses of RP3 (IT) in HSV seronegative participants.

Group II: Dose escalation of RP3 - superficial and/or deep/visceral tumorsExperimental Treatment1 Intervention

Dose escalation of RP3 alone in 2 cohorts with intratumoral (IT) injections including use of imaging guided injection for deep tumors.

Group III: Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumorsExperimental Treatment2 Interventions

Dose combination of RP3 and anti-PD1 therapy. IT injections of RP3 including use of imaging guided injection for deep tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapy, including checkpoint inhibitors such as nivolumab and investigational drugs like RP3, enhances the body's immune response against cancer cells by blocking proteins that inhibit immune cell activity. This mechanism boosts the immune system's ability to target and destroy tumor cells, offering a more targeted and potentially more effective treatment option for solid tumor patients, with the added benefit of potentially fewer side effects compared to traditional therapies like chemotherapy.