Trials / Terminated
TerminatedNCT03386721
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
- First posted
- 2017-12-29
- Last updated
- 2023-02-21
- Results posted
- 2023-02-21
Locations
44 sites across 15 countries: United States, Belgium, France, Germany, Israel, New Zealand, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03386721. Inclusion in this directory is not an endorsement.