Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Replimune, Inc.
Study ID
NCT03767348
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Cutaneous Melanoma
  • Microsatellite Instability-High (MSI-H)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Non-melanoma Skin Cancer (NMSC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP1 — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus
  • nivolumab — BIOLOGICAL
    anti-PD-1 monoclonal antibody

Study Details

The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).

Key Dates

Start date
Sep 20, 2017
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
    anti-PD-1 monoclonal antibody
  • 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 superficial tumors
  • Experimental: Dose expansion of RP1 and nivolumab (IV) in superficial tumors
    Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
  • 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

Primary Outcome Measure

Percentage of adverse events (AEs) [ Time Frame: 26 months ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Birmingham AlabamaBirminghamAlabama35294-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo ClinicPhoenixArizona85054-
Carti Cancer CenterLittle RockArkansas72205-
UC San DiegoLa JollaCalifornia92093-
UCLALos AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of California, IrvineOrangeCalifornia92868-
University of California- San FranciscoSan FranciscoCalifornia94115-
Sylvester Comprehensive Cancer Center- University of MiamiMiamiFlorida33136-
University of Iowa-Cancer Center ResearchIowa CityIowa52242-
James Graham Brown Cancer Center- University of LouisvilleLouisvilleKentucky40202-
Mayo ClinicRochesterMinnesota55905-
New York University Clinical Cancer CenterNew YorkNew York10016-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
Duke Cancer CenterDurhamNorth Carolina27710-
University of Cincinnati Medical CenterCincinnatiOhio45267-
Providence Portland Medical CenterPortlandOregon97213-
MUSC HealthCharlestonSouth Carolina29425-
West Cancer CenterGermantownTennessee38138-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Eccles Outpatient Care Center- Oncology Clinical TrialsMurrayUtah84107-
Intermountain Cancer Center- Saint George Cancer CenterSt. GeorgeUtah84790-
Seattle Cancer Care Alliance- University of WashingtonSeattleWashington98109-
University of Wisconsin-Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
University of Birmingham Alabama· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZMayo Clinic· Phoenix, AZCarti Cancer Center· Little Rock, ARUC San Diego· La Jolla, CAUCLA· Los Angeles, CA

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