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NCT03386721 · ClinicalTrials.gov registry record · Phase 2
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
NCT03386721: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT03386721 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 256 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386721, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
Study 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.
Primary Outcome
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off
Interventions
- DRUG Gemcitabine
- DRUG Vinorelbine
- DRUG Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
- DRUG simlukafusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2021-12-30 |
| Phase | Phase 2 |
Why NCT03386721 stopped before completion
NCT03386721 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 4 interventions - of which Gemcitabine is the first listed.
NCT03386721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03386721 about?
NCT03386721 is a clinical study titled "Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors". 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 ca...
What is the current status of trial NCT03386721?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2018-02-19. Estimated completion is 2021-12-30.
What interventions are being tested in trial NCT03386721?
The interventions under investigation include: Gemcitabine (DRUG), Vinorelbine (DRUG), Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody (DRUG), simlukafusp alfa (DRUG).
Who is sponsoring clinical trial NCT03386721?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386721's enrollment target sits among peer trials
256 215th of 2000 higher than 1,783 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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