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NCT01656642
A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma
Phase 1 trial testing Atezolizumab in Malignant Melanoma in 67 participants. Completed in 25 March 2020.
25 March 2020
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 13 August 2012 |
| Primary completion | 25 March 2020 |
| Estimated completion | 25 March 2020 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Atezolizumab (atezolizumab) — full drug profile →
- Cobimetinib (cobimetinib) — full drug profile →
- Vemurafenib (vemurafenib) — full drug profile →
Conditions studied
- Malignant Melanoma — all drugs for Malignant Melanoma →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter, Phase Ib, dose-escalation and cohort-expansion study of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with vemurafenib or vemurafenib plus cobimetinib in participants with BRAFV600-mutation positive metastatic melanoma. Enrolled participants may continue treatment until they are no longer experiencing clinical benefit as assessed by the investigator and in alignment with the protocol.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Next Immune-Checkpoint Inhibitors: PD-1/PD-L1 Blockade in Melanoma.
Mahoney KM, Freeman GJ, McDermott DF. · · 2015 · cited 440× · PMID 25823918 · DOI 10.1016/j.clinthera.2015.02.018 -
Melanoma treatment in review.
Domingues B, Lopes JM, Soares P, Pópulo H. · · 2018 · cited 432× · PMID 29922629 · DOI 10.2147/itt.s134842 -
Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer.
Sznol M, Chen L. · · 2013 · cited 418× · PMID 23460533 · DOI 10.1158/1078-0432.ccr-12-2063 -
Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2 -
Breathing new life into immunotherapy: review of melanoma, lung and kidney cancer.
Drake CG, Lipson EJ, Brahmer JR. · · 2014 · cited 313× · PMID 24247168 · DOI 10.1038/nrclinonc.2013.208 -
PD-1 as a potential target in cancer therapy.
McDermott DF, Atkins MB. · · 2013 · cited 309× · PMID 24403232 · DOI 10.1002/cam4.106 -
Lessons learned from the blockade of immune checkpoints in cancer immunotherapy.
Li X, Shao C, Shi Y, Han W. · · 2018 · cited 284× · PMID 29482595 · DOI 10.1186/s13045-018-0578-4 -
Antagonists of PD-1 and PD-L1 in Cancer Treatment.
Lipson EJ, Forde PM, Hammers HJ, Emens LA, et al · · 2015 · cited 236× · PMID 26320063 · DOI 10.1053/j.seminoncol.2015.05.013
Verify or expand the search:
- PubMed search for NCT01656642
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Malignant Melanoma
Currently open trials in the same condition.
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Other Genentech, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01656642 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
- Last refreshed: 21 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01656642.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing