Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT05852691 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Nab-Paclitaxel
  • DRUG Tobemstomig

Study Locations (20)

Other

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires
  • Fakultni Thomayerova nemocnice — Praha 4 - Krc
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH — Essen
  • Dres. Andreas Köhler und Roswitha Fuchs — Langen
  • Universitätsklinikum Ulm Am Michelsberg — Ulm
  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz — Tatabánya
  • Hadassah University Hospital - Ein Kerem — Jerusaelm
  • Sheba Medical Center — Ramat Gan

São Paulo

  • Hospital de Cancer de Barretos — Barretos
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo

California

  • Cancer Blood and Specialty Clinic — Los Alamitos

New York

  • Memorial Sloan-Kettering Cancer Center — New York

North Carolina

  • Novant Health Presbyterain Medical Center — Charlotte

South Dakota

  • Avera Cancer Institute — Sioux Falls

Victoria

  • Sunshine Hospital — St Albans

Goiás

  • Hospital Araujo Jorge — Goiânia

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2023-07-18
Est. Completion 2026-10-31
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05852691

The ClinicalTrials.gov registry entry for NCT05852691 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05852691 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, São Paulo, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05852691 about?

NCT05852691 is a clinical study titled "A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer". The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negati...

What is the current status of trial NCT05852691?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2023-07-18. Estimated completion is 2026-10-31.

What conditions does trial NCT05852691 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05852691?

The interventions under investigation include: Pembrolizumab (DRUG), Nab-Paclitaxel (DRUG), Tobemstomig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05852691?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05852691 being conducted?

This trial has 20 study locations across California, New York, North Carolina, South Dakota, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial