Neoplasms

All Conditions

Infections

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Virus Diseases

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Cemiplimab

Antineoplastic Agents, Immunological

Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks

Cemiplimab administered intravenously as a single therapy every 3 weeks

Sumera Raoof, MD

Jeannie Hou, MD

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals

Replimune Inc.

Patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC.

Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R-

Sherrif Ibrahim, MD. PhD

Catherine VanHooft, HT

Catherine VanHooft, BA

Sherrif Ibrahim, MD, PhD

This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC. The enrollment of patients with CSCC will determine study duration.

Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.

A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC

To evaluate efficacy by one-year disease free survival (DFS) rates in CSCC and all patients treated, according to investigator review

The proportion of patients with pathologic complete response (pCR) per Immune-Related Pathologic Response Criteria' (irPRC) criteria: 0% residual viable tumor (RVT)\] remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery.

To estimate duration of response (DOR) for CSCC and all patients treated, by investigator review.

To estimate the progression-free (PFS) for CSCC and all patients treated.

Estimate the complete response (CR) rate for CSCC and all patients treated.

To evaluate the disease control rate (DCR) for CSCC and all patients treated.

Sherrif Ibrahim

Principal Investigator

Symptoms and General Pathology

Rare Diseases

Melanoma

Microsatellite Instability

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Genomic Instability

Turcot Syndrome

Neuroendocrine Tumor

Neuroepithelioma

Antibodies

Antibodies, Monoclonal

Nivolumab

Immunoglobulins

Immune Checkpoint Inhibitors

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

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

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

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

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

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

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

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

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

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

Genetically modified herpes simplex type 1 virus

nivolumab

Clinical Trials at Replimune

Jenesse Moffett

Jiaxin Niu, MD

Mahesh Seetharam, MD

Issam Makhoul, MD

Gino In, MD

Danell Johnson

Bartosz Chmielowski, MD

John Fruehauf, MD

Melissa Chow

Katy Tsai, MD

Estelamari Rodriguez, MD

Mariel McKay

Mohammed Milhem, MBBS

Stacy Baum

Jason Chesney, MD

Robert McWilliams, MD

Eric Whitman, MD

Anna Pavlick, DO

Delaney Dretto

Janice Cifelli

Rachael Turner, MD

Georgia Beasley, MD

Trisha Wise-Draper, MD

John Kaczmar, MD

Alisa Harber

Ari Vanderwalde, MD

Michael Wong, MD

Tawnya Bowles

Tawnya Bowles, MD

Angi Cox

Terence Rhodes, MD

Katie Kim

Evan Hall, MD

Nardin Charlee, MD

Antoine Italiano, MD

Sophie Dalac-Rat, MD

Mona AMINI-ADLE, MD

Caroline Gaudy, MD

Henri Montaudie, MD

Céleste Lebbe, MD

Judith Michels, MD

Sebastian Ochsenreither, MD

Dirk Schadendorf, MD

Katharina Kahler, MD

Martin Gschnell, MD

Eva Couselo Munoz, MD

Ana Arance Fernández, MD

Juan Liberal Martin, MD

Miguel Fernández de Sanmamed

Pablo Cerezuela, MD

Miguel Gutiérrez Sanmamed, MD

Ana Gill, MD

Alfonso Jaime Berrocal, MD

Adel Samson, MD

Mark R Middleton, MD,PhD,FRCP

Patricia Roxburgh, MD

Joseph Sacco, MRCP, PhD

Kevin Harrington, BSc FRCP PhD

Ioannis Karydis, MD

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.

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.

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

Percentage of subjects with adverse events (AEs)

Percentage of subjects with serious adverse events (SAEs)

Percentage of subjects with dose limiting toxicities (DLTs)

Percentage of overall response rate (ORR) for all participants

Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation

Percentage of subjects with biological activity determined by tumor biopsies and biomarker data

Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1

Percentage of subjects with a complete response (CR)

Median duration of progression-free survival of subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer	NCT04050436	Cutaneous Squam... Advanced Cutane... Metastatic Cuta...	Cemiplimab RP1	18 Years -	Replimune Inc.
Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.	NCT05858229	Squamous Cell C... RP1	RP1	18 Years -	Rochester Dermatologic Surgery
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab	NCT03767348	Cancer Melanoma (Skin) Mismatch Repair... Microsatellite ... Non-melanoma Sk... Cutaneous Melan... NSCLC	RP1 nivolumab	18 Years -	Replimune Inc.
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer	NCT04050436	Cutaneous Squam... Advanced Cutane... Metastatic Cuta...	Cemiplimab RP1	18 Years -	Replimune Inc.
Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.	NCT05858229	Squamous Cell C... RP1	RP1	18 Years -	Rochester Dermatologic Surgery

Spots Global Cancer Trial Database for rp1

Every month we try and update this database with for rp1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rp1

Every month we try and update this database with for rp1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rp1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.