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Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

NCT03386721 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-02-21

Study results available
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Summary

This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.

Conditions

  • Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers

Interventions

DRUG

simlukafusp alfa

simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.

DRUG

Gemcitabine

Single-agent treatment administered as per approved protocol.

DRUG

Vinorelbine

Single-agent treatment administered as per approved protocol.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Israel
  • New Zealand
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386721 on ClinicalTrials.gov