Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Launched by REPLIMUNE INC. · Dec 5, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Study of RP1 Monotherapy and RP1 in Combination With Nivolumab," is testing a new treatment for patients with advanced cancers, including melanoma and non-small cell lung cancer (NSCLC). The goal is to find out the highest safe dose of RP1 when given alone and with another drug called nivolumab, which is already used for some cancers. The researchers also want to see how effective this treatment is for patients who have not responded well to other therapies.

To be eligible for the trial, participants need to be adults with certain types of advanced cancer and have a good performance status, meaning they can carry out daily activities without much difficulty. They should have at least one tumor that can be measured and injected for treatment. The trial is open to both men and women aged 65 and older. Participants will receive the study treatment and be closely monitored for its effects and potential side effects. It’s important to note that those with a history of certain viral infections or untreated brain metastases, among other criteria, may not be able to participate. If you're considering this trial, it could be an opportunity to access new treatment options while contributing to cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• • At least one measurable and injectable lesion
• • Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
• • Have a predicted life expectancy of ≥ 3 months
• • Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
• • Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy.
• • Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment.
• • Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
• • Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment.
• Exclusion Criteria:
• • Prior treatment with an oncolytic therapy
• • History of viral infections according to the protocol
• • Prior complications with herpes infections
• • Chronic use of anti-virals
• • Uncontrolled/untreated brain metastasis
• • History of interstitial lung disease
• • History of non-infectious pneumonitis
• • History of clinically significant cardiovascular disease