Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
217
Countries
4
Sites
26
Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
To evaluate the safety and tolerability of Arm A (tobemstomig + axitinib) vs. Control Arm (pembrolizumab + axitinib) and Arm B (Tiragolumab + tobemstomig + axitinib) vs. Control Arm in the safety evaluable (SE) population
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Apr 2023 → ongoing
- Decision date (initial)
- 2024-05-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-505816-39-00
- EudraCT number
- 2021-006430-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety
To evaluate the safety and tolerability of Arm A (tobemstomig + axitinib) vs. Control Arm (pembrolizumab + axitinib) and Arm B (Tiragolumab + tobemstomig + axitinib) vs. Control Arm in the safety evaluable (SE) population
Conditions and MedDRA coding
Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10050513 | Metastatic renal cell carcinoma | 100000004864 |
| 25.0 | LLT | 10086821 | Advanced renal cell carcinoma | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- International Metastatic Renal Cell Carcinoma Database Consortium IMDC risk intermediate (score of 1 or 2), or poor (score of 3 to 6)
- Measurable disease, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Adequate hematologic and end-organ function (within 14 days prior to study treatment)
- Histologically confirmed clear-cell renal cell carcinoma renal cell carcinoma (ccRCC) with or without sarcomatoid features; non-clear-cell renal cell carcinoma (nccRCC) subtypes (papillary, chromophobe, and unclassified) are not allowed.
- Negative hepatitis B surface antigen (HBsAg) test and hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening
Exclusion criteria 6
- Prior treatment for localized and/or metastatic RCC with systemic RCC directed therapy
- Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease
- Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment.
- Moderate to severe hepatic impairment (Child-Pugh B or C)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Incidence and severity of adverse events, with severity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. with the exception of cytokine release syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
—
SCP138385 · ATC
- Substance synonyms
- AG-013,736
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeled and re-packaged for Clinical Trial Use
—
PRD9859362 · Product
- Other product name
- TOBEMSTOMIG
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD7846761 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
—
PRD4323105 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeled and re packaged for Clinical Trial Use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Charles River Laboratories Montreal ULC ORG-100041009
|
Senneville, Canada | Laboratory analysis |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Swm Partners Limited ORG-100047818
|
Berkhamsted, United Kingdom | Other |
| MicroCoat Biotechnologie GmbH ORG-100031937
|
Bernried Am Starnberger See, Germany | Laboratory analysis |
Locations
4 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 14 | 6 |
| Germany | Ongoing, recruitment ended | 28 | 6 |
| Poland | Ongoing, recruitment ended | 40 | 6 |
| Spain | Ongoing, recruitment ended | 31 | 8 |
| Rest of world
China, United Kingdom, Canada, United States, Korea, Republic of, Australia
|
— | 104 | — |
Investigational sites
Institut Gustave Roussy
oncologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Sainte Catherine Institut Du Cancer Avignon-Provence
oncologie, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Leon Berard
oncologie, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Bordeaux
oncologie, 1 Rue Jean Burguet, 33000, Bordeaux
Besancon University Hospital Center
oncologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Francois Baclesse
oncologie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Universitätsklinikum Hamburg-Eppendorf
Martini-Klinik im UKE, Martinistraße 52, 20246, Hamburg
Klinikum rechts der Isar der TU Muenchen AöR
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitätsklinikum Carl Gustav Carus
Klinik für Urologie, Fetscherstr. 74, 01307, Dresden,
Studienpraxis Urologie
n/a, Steinengrabenstr. 17, 72622, Nürtingen
Medizinische Hochschule Hannover
Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Ulm AöR
Klinik für Urologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Onkologii, Oddział Chemioterapii, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Oddział Chemioterapii, Ul. Grenadierow 51/59, 04-073, Warsaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambolutorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Onkologii Klinicznej, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Onkologii i Poradnia Onkologiczna, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Hospital Universitari Vall D Hebron
Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico San Carlos
Oncologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Reina Sofia
Oncologia, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital De La Santa Creu I Sant Pau
Oncologia, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-05-03 | 2025-10-30 | 2023-07-11 | 2024-07-11 | |
| Germany | 2023-10-09 | 2023-10-30 | 2024-07-11 | ||
| Poland | 2023-04-04 | 2023-04-12 | 2024-07-11 | ||
| Spain | 2023-04-18 | 2023-04-25 | 2024-07-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 39 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PCL 2023-505816-39-00 Redacted | n/a |
| Protocol (for publication) | D1_Protocol 2023-505816-39-00 Redacted | 6 |
| Recruitment arrangements (for publication) | K Recruitment arrangements Note to File | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_filenote | 2 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_filenote | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_Note to file | 2 |
| Recruitment arrangements (for publication) | K1_Document additionnel CTR_for publication | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and Optional ICF Biopsy | 1 |
| Subject information and informed consent form (for publication) | L1 SIS Annex1 ICFv3 18 Aug 2024 Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_BO43936_DEU_ICF_Addendum_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_BO43936_DEU_ICF_Main_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_BO43936_DEU_ICF_RBR | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Apparent Progression | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant health | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional biopsy | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_Note to File | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner authorization | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF principal_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 3 |
| Subject information and informed consent form (for publication) | L2 SIS and Infant authorization form | 2 |
| Subject information and informed consent form (for publication) | L3 SIS and ICF Main Redacted | 4 |
| Subject information and informed consent form (for publication) | L4 SIS and ICF Pregnant partner | 2 |
| Subject information and informed consent form (for publication) | L5 SIS and ICF RBR | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC AXITINIB | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-pembrolizumab | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-505816-39-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-505816-39-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-505816-39-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-505816-39-00 | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-505816-39-00_redline | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-505816-39-00_redline | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-2023-505816-39-00_redline | 3.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-505816-39-00_redline | 3.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-12 | Germany | Acceptable 2024-04-10
|
2024-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Germany | Acceptable 2024-09-23
|
2024-09-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-28 | Germany | Acceptable 2024-09-23
|
2024-10-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-30 | Acceptable | 2024-12-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-30 | Germany | Acceptable | 2024-11-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-05 | Acceptable | 2024-12-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-18 | Acceptable | 2025-02-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-03 | Germany | Acceptable 2025-05-05
|
2025-05-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-21 | Germany | Acceptable 2026-01-26
|
2026-01-28 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-04 | Germany | Acceptable 2026-04-17
|
2026-04-20 |