Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Study Purpose

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03767348
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Replimune Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeannie Hou, MD
Principal Investigator Affiliation	Replimune Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Germany, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Melanoma (Skin), Mismatch Repair Deficiency, Microsatellite Instability, Non-melanoma Skin Cancer, Cutaneous Melanoma, NSCLC

Additional Details

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

Arms & Interventions

Arms

Experimental: Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors

Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors

Experimental: Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors

Dose escalation of RP1 alone in 3 cohorts with IT injections in deep/visceral tumors

Experimental: Dose expansion of RP1 and nivolumab (IV) in superficial tumors

Doses of RP1 (IT) in superficial tumors with nivolumab (IV)

Experimental: Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors

Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)

Experimental: RP1 (IT) and nivolumab (IV) in melanoma

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma

Experimental: RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors

Experimental: RP1 (IT) and nivolumab (IV) in NMSC

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer

Experimental: RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma

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

Experimental: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC

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

Experimental: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC

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

Interventions

Biological: - RP1

Genetically modified herpes simplex type 1 virus

Biological: - nivolumab

anti-PD-1 monoclonal antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Birmingham Alabama, Birmingham, Alabama

Status

Active, not recruiting

Address

University of Birmingham Alabama

Birmingham, Alabama, 35294

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