A Study of Tobemstomig/RO7247669 Combined with Nab-Paclitaxel Compared with Pembrolizumab Combined with Nab-Paclitaxel in Participants with Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Overview

Sponsor-declared trial summary

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

13 Mar 2024 → 5 Aug 2025

Decision date (initial)

2023-08-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the efficacy of tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in the full analysis set (FAS) based on progression-free survival (PFS)

Secondary objectives 2

1. To evaluate the efficacy of tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in the FAS on the basis of objective response rate (ORR), duration of response (DOR), overall survival (OS)
2. To evaluate the safety of tobemstomig plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in the safety analysis set (SAS)

Conditions and MedDRA coding

Triple-Negative Breast Cancer (TNBC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Metastatic or locally advanced unresectable, histologically documented TNBC [absence of human epidermal growth factor receptor 2 (HER2)-over-expression, estrogen receptor (ER), and progesterone receptor (PgR) expression by local assessment]
2. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). If metastatic disease (Stage IV), measurable disease outside of the bone
3. No prior systemic therapy for metastatic or locally advanced unresectable TNBC
4. Tumor programmed death-ligand 1 (PD-L1) expression as documented through central testing of a representative tumor tissue specimen
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
6. Adequate hematologic and end-organ function, defined by protocol-specified laboratory test results, obtained within 14 days prior to initiation of study treatment

Exclusion criteria 6

1. History of malignancy within 5 years prior to consent
2. Poor venous access
3. History of leptomeningeal disease
4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
5. Major surgical procedure within 4 weeks prior to initiation of study treatment
6. Prior treatment with CD137 agonists or anti-cytotoxic T-lymphocyte-associated protein (CTLA) therapeutic antibodies or an anti-lymphocyte-activation gene 3 protein (LAG-3) agent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (FAS)

Secondary endpoints 6

1. Objective response rate (ORR)
2. Duration of response (DOR)
3. Overall survival (OS)
4. Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5.0)
5. Change from baseline in targeted clinical laboratory test results
6. Change from baseline in targeted vital signs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 1

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 Town

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 6

Locations

8 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 62 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications