Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

  • STATUS
    Recruiting
  • End date
    Nov 24, 2024
  • participants needed
    300
  • sponsor
    Replimune Inc.
Updated on 1 August 2021
cancer
measurable disease
carcinoma
melanoma skin
squamous cell carcinoma
BRAF
oximetry
progressive disease
nivolumab
primary cancer
solid tumour
solid neoplasm
bladder cancer
bladder tumor
malignant melanoma of skin
merkel cell carcinoma

Summary

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.

Description

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.

Details
Condition Non-Small Cell Lung Cancer, urinary tract neoplasm, Microsatellite Instability, Cancer, bladder cancer, bladder disorder, melanoma, skin cancer, Metastatic Melanoma, Cancer/Tumors, Ewing's Family Tumors, Urothelial Cancer, Cancer (Pediatric), Mismatch Repair Deficiency, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Malignant Melanoma, Neoplasms, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, Melanoma, Uveal, Melanoma, Ocular, Non-melanoma Skin Cancer, primary cancer, primary malignant neoplasm, melanoma skin, melanoma skin cancer, malignant melanoma of skin, malignancy, cancers, malignancies, malignant tumor, malignant tumors, nsclc, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer
Treatment Nivolumab, RP1
Clinical Study IdentifierNCT03767348
SponsorReplimune Inc.
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
At least one measurable and injectable lesion
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) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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) for whom anti-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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: has confirmed progressive disease after no more than two prior systemic treatments including anti-PD1/PD-L1 treatment
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

Exclusion Criteria

Uncontrolled/untreated brain metastasis
History of non-infectious pneumonitis
History of clinically significant cardiovascular disease
Prior treatment with an oncolytic therapy
History of viral infections according to the protocol
Prior complications with herpes infections
Chronic use of anti-virals
History of interstitial lung disease
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