NCT01633970

A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Completed Phase 1 Last updated 8 October 2020

What this trial tests

Phase 1 trial testing 5-FU in Cancer in 240 participants. Completed in 26 February 2020.

Timeline

11 July 2012

Primary endpoint
26 February 2020

26 February 2020

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	11 July 2012
Primary completion	26 February 2020
Estimated completion	26 February 2020
Sites	11 locations across United States

Drugs / interventions tested

• 5-FU
• Atezolizumab
• Bevacizumab
• Carboplatin
• Leucovorin (leucovorin) — full drug profile →
• Nab-paclitaxel
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Paclitaxel — full drug profile →
• Pemetrexed — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Genentech, Inc. — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-label, Phase Ib study that has six treatment arms is designed to assess the safety, pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered anti-programmed death-ligand 1 \[PDL1\] antibody) administered with bevacizumab (Arm A) and with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B), with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with locally advanced or metastatic solid tumors. The study includes dose escalation cohort for establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then expansion cohort will be initiated based on a selected dose level at or below the MTD or MAD.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in colorectal cancer: rationale, challenges and potential.
   Ganesh K, Stadler ZK, Cercek A, Mendelsohn RB, et al · · 2019 · cited 1407× · PMID 30886395 · DOI 10.1038/s41575-019-0126-x
2. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies.
   Naidoo J, Page DB, Li BT, Connell LC, et al · · 2015 · cited 1005× · PMID 26371282 · DOI 10.1093/annonc/mdv383
3. Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study.
   Dirix LY, Takacs I, Jerusalem G, Nikolinakos P, et al · · 2018 · cited 598× · PMID 29063313 · DOI 10.1007/s10549-017-4537-5
4. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma.
   Wallin JJ, Bendell JC, Funke R, Sznol M, et al · · 2016 · cited 537× · PMID 27571927 · DOI 10.1038/ncomms12624
5. Vascular normalization as an emerging strategy to enhance cancer immunotherapy.
   Huang Y, Goel S, Duda DG, Fukumura D, et al · · 2013 · cited 518× · PMID 23440426 · DOI 10.1158/0008-5472.can-12-4354
6. Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment.
   Yi M, Jiao D, Qin S, Chu Q, et al · · 2019 · cited 487× · PMID 30925919 · DOI 10.1186/s12943-019-0974-6
7. 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
8. 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