Immunotherapy for Triple-Negative Breast Cancer

Recruiting in Palo Alto (17 mi)

+145 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. Participants must have no prior treatments for their condition, measurable disease per RECIST v1.1 criteria, good performance status (ECOG 0 or 1), adequate organ function, and negative tests for HIV and hepatitis. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

You have tested negative for hepatitis B surface antigen (HBsAg) at the screening.

My breast cancer is advanced, cannot be surgically removed, and lacks HER2, ER, and PgR.

My tumor has been tested and shows PD-L1 expression.

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Exclusion Criteria

I don't have any health issues that would make it unsafe for me to take a new drug.

I have not received a live vaccine in the last 28 days.

I haven't taken any immune-boosting drugs in the last 4 weeks or longer.

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Treatment Details

Interventions

Nab-Paclitaxel (Anti-microtubule agent)
Pembrolizumab (PD-L1 Inhibitor)
RO7247669 (PD-L1 Inhibitor)

Trial OverviewThe study compares the effectiveness of a new immunotherapy drug called Tobemstomig combined with Nab-Paclitaxel versus Pembrolizumab (an existing treatment) plus Nab-Paclitaxel in treating advanced triple-negative breast cancer that expresses PD-L1.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment2 Interventions

Participants will receive tobemstomig every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Group II: Arm BActive Control2 Interventions

Participants will receive pembrolizumab every 3 weeks, plus nab-paclitaxel administered on a repeating schedule of 3 weeks on, 1 week off, until disease progression or until up to 24 months after the first treatment, whichever is sooner.

Nab-Paclitaxel is already approved in Canada for the following indications: