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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

Completed Phase 1 Last updated 21 July 2020
What this trial tests

Phase 1 trial testing Atezolizumab in Malignant Melanoma in 67 participants. Completed in 25 March 2020.

Timeline
13 August 2012
Primary endpoint
25 March 2020
25 March 2020

Quick facts

Lead sponsorGenentech, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment67
Start date13 August 2012
Primary completion25 March 2020
Estimated completion25 March 2020
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. Melanoma treatment in review.
    Domingues B, Lopes JM, Soares P, Pópulo H. · · 2018 · cited 432× · PMID 29922629 · DOI 10.2147/itt.s134842
  3. 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
  4. 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
  5. 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
  6. PD-1 as a potential target in cancer therapy.
    McDermott DF, Atkins MB. · · 2013 · cited 309× · PMID 24403232 · DOI 10.1002/cam4.106
  7. 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
  8. 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:

Other trials of Atezolizumab

Trials testing the same drug.

Other recruiting trials for Malignant Melanoma

Currently open trials in the same condition.

Other Genentech, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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