Clinical trial • Phase I/II • Oncology

CEMIPLIMAB for Melanoma|Advanced solid tumours|Clear-cell renal cell carcinoma (ccRCC)

Phase I/II trial of CEMIPLIMAB for Melanoma|Advanced solid tumours|Clear-cell renal cell carcinoma (ccRCC).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Melanoma|Advanced solid tumours|Clear-cell renal cell carcinoma (ccRCC)
Trial Stage
Phase I/II
Drug Modality
Monoclonal antibody|Other antibody

Key dates

Initial CTIS Submission Date
16-01-2026
First CTIS Authorization Date
08-05-2026

Trial design

open-label, regn10597 alone; regn10597 in combination with cemiplimab. no placebo or other active comparator specified.-controlled, adaptive Phase I/II trial in France, Germany, Italy and others.

Open Label
Yes
Comparator
REGN10597 alone; REGN10597 in combination with cemiplimab. No placebo or other active comparator specified.
Adaptive
True, study includes a first-in-human dose-escalation phase (conducted in US) and dose-expansion cohorts (conducted globally) with dose-escalation rules and DLT evaluation to guide escalation and cohort expansion.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
134

Eligibility

Recruits 134 No vulnerable populations selected; trial enrols adults ≥18 years of age. Informed consent is required from participants themselves; no assent procedures for minors are described in the application..

Vulnerable Population
No vulnerable populations selected; trial enrols adults ≥18 years of age. Informed consent is required from participants themselves; no assent procedures for minors are described in the application.

Inclusion criteria

  • {"criterion_text":"- Adult participants ≥18 years of age\n- Dose escalation cohorts: Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available\n- Dose expansion cohorts: Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol. ALL participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points\n- NOTE: Other Protocol Defined Inclusion Criteria Apply"}

Exclusion criteria

  • {"criterion_text":"- Prior treatment with Interleukin 2 (IL2)/IL15/IL7 given outside the context of concurrent administration with adoptive cell therapy\n- Prior treatment with anti PD-1/PD-L1 therapy, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol\n- Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs\n- Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities\n- Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol\n- Has known allergy or hypersensitivity to components of the study drugs\n- Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention\n- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments\n- NOTE: Other Protocol Defined Exclusion Criteria Apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of Dose-Limiting Toxicities (DLTs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of Treatment-Emergent Adverse Event (TEAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of Serious Adverse Events (SAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of TEAEs leading to treatment discontinuation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of TEAEs leading to death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with Grade ≥3 laboratory abnormalities","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment","definition_or_measurement_approach":"Assessed per RECIST 1.1 by investigator assessment"}

Secondary endpoints

  • {"endpoint_text":"- ORR based on RECIST 1.1 criteria by investigator assessment","definition_or_measurement_approach":"Assessed per RECIST 1.1 by investigator assessment"}
  • {"endpoint_text":"- Best Overall Response (BOR) based on RECIST 1.1 criteria","definition_or_measurement_approach":"Assessed per RECIST 1.1"}
  • {"endpoint_text":"- Duration Of Response (DOR) based on RECIST 1.1 criteria","definition_or_measurement_approach":"Assessed per RECIST 1.1"}
  • {"endpoint_text":"- Disease control rate based on RECIST 1.1","definition_or_measurement_approach":"Assessed per RECIST 1.1"}
  • {"endpoint_text":"- Time to response based on RECIST 1.1","definition_or_measurement_approach":"Assessed per RECIST 1.1"}
  • {"endpoint_text":"- Progression Free Survival (PFS) based on RECIST 1.1","definition_or_measurement_approach":"Assessed per RECIST 1.1"}
  • {"endpoint_text":"- Concentrations of REGN10597 in serum","definition_or_measurement_approach":"Serum concentration measurements of REGN10597 over time"}
  • {"endpoint_text":"- Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time","definition_or_measurement_approach":"Incidence of ADA measured over time"}
  • {"endpoint_text":"- Magnitude of ADA to REGN10597 over time","definition_or_measurement_approach":"Magnitude (titer/level) of ADA measured over time"}

Recruitment

Planned Sample Size
134
Recruitment Window Months
46
Consent Approach
Informed consent obtained from adult participants (participants ≥18 years). Country-specific Subject Information and Informed Consent Forms (SIS-ICF) are provided in French, German, Italian and Spanish (documents listed per Member State). Optional ICF modules (e.g. PGx, pregnant partner, continued participation) are included. No assent procedures for minors are described.

Methods

  • Patient recruitment activities (Clariness GmbH) listed as 'Patient Recruitment' (contact support@clariness.com) — referenced for Germany.
  • Country-specific recruitment procedure and recruitment materials documents submitted for France, Germany, Italy and Spain (K1/K2 recruitment documents present in application).
  • Centralised feasibility and site support activities provided by WCG Clinical Inc. (Feasibility) and IQVIA entities (investigator/site support emails present).

Geography

Total Number Of Sites
19
Total Number Of Participants
99

France

Earliest CTIS Part Ii Submission Date
03-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
38
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Dermatology department
Contact Person Name
Laurent Mortier
Contact Person Email
laurent.mortier@chu-lille.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology Department
Contact Person Name
Damien Pouessel
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Dermatology department
Contact Person Name
Celeste Lebbe
Contact Person Email
celeste.lebbe@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology Department
Contact Person Name
Laurence Albiges

Germany

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
11
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
SLK-Kliniken Heilbronn GmbH
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slkkliniken.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Onkologische Studienzentrale
Contact Person Name
Winfried Henning Alsdorf
Contact Person Email
w.alsdorf@uke.de
Site Name
Universitaetsklinikum Erlangen AöR
Contact Person Name
Silvia Spoerl
Contact Person Email
silvia.spoerl@uk-erlangen.de
Site Name
Universitaetsklinikum Bonn AöR
Contact Person Name
Georg Feldmann
Contact Person Email
Georg.Feldmann@ukbonn.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Dermatologie
Contact Person Name
Dirk Schadendorf
Contact Person Email
dirk.schadendorf@uk-essen.de

Italy

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
42
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia clinica sperimentale del melanoma - immunoterapia e terapie innovative
Contact Person Name
Paolo Antonio Ascierto
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia Medica ed Ematologia
Contact Person Name
Michele Del Vecchio
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Ernesto Rossi
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Contact Person Name
Michele Milella
Contact Person Email
michele.milella@univr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
25
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology Service
Contact Person Name
Jorge Bartolome Arcilla
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology Service
Contact Person Name
Begoña Perez Valderrama
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology Service
Contact Person Name
Maria Julia Lostes Bardaji
Contact Person Email
jlostes@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology Service
Contact Person Name
Aranzazu Manzano Fernandez
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology Service
Contact Person Name
Valentina Gambardella
Contact Person Email
vgambardella@incliva.es

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Primary CRO

Third parties

  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Central laboratory","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Clinical supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Specialty laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Primary CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Feasibility","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
LIBTAYO 350 mg concentrate for solution for infusion.
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation number EU/1/19/1376/001)
Investigational Product Name
REGN10597
Active Substance
IGG4 ANTIBODY FRAGMENT AGAINST PROGRAMMED CELL DEATH PROTEIN 1 FUSED WITH INTERLEUKIN-2 AND AN ANTIBODY FRAGMENT AGAINST INTERLEUKIN-2 RECEPTOR SUBUNIT ALPHA
Modality
Other antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Investigational (no marketing authorisation indicated)
First In Human
Yes
Combination Treatment
Yes

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