5-FU
DrugParticipants will receive 5-FU 400 mg/m^2 IV q2w.
NCT Number: NCT01633970
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.
Looking for future studies?
Notify MeHealthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General Inclusion Criteria:
Eligible Tumor Types:
Arm A Escalation Cohorts and Arms A and B Biopsy Cohort (Cutaneous/Subcutaneous Lesions)
Arm A renal cell carcinoma (RCC) Cohort:
Arm A Tumor Type-Specific Cohort:
Gastric Cancer:
Ovarian Cancer:
Bladder Cancer:
Cervical Cancer:
Arms C, D, and E Cohorts:
Arm F Cohort:
Tumor molecular status:
Arm A safety expansion cohort
Exclusion criteria
General Exclusions
Arm A Tumor Type-Specific Cohort:
Gastric Cancer:
Ovarian Cancer:
Cervical Cancer:
Exclusion criteria
Unique to Arm B:
Exclusion criteria
Unique to Arms C, D, and E:
Exclusion criteria
Unique to Arm F:
Participants will receive 5-FU 400 mg/m^2 IV q2w.
Participants will receive IV atezolizumab (800 mg q2w or 1200 mg q3w) q3w.
Other names: MPDL3280A
Participants will receive bevacizumab 10 mg/kg or 15 mg/kg IV q3w.
Other names: Avastin
Participants will receive carboplatin IV q3w with target AUC of 6 mg/mL.
Participants will receive leucovorin 400 mg/m^2 IV q2w.
Participants will receive nab-paclitaxel 100 mg/m^2 IV qw.
Participants will receive oxaliplatin 85 mg/m^2 IV q2w.
Participants will receive paclitaxel 200 mg/m^2 IV q3w.
Participants will receive pemetrexed 500 mg/m^2 IV q3w.
Time frame: Days 1-21 of Cycle 1 (Cycle length = 21 days) for Arms A, C, D and E and the 28 days following the first administration of atezolizumab in Arm B
Time frame: From Baseline up to 90 days after last dose of study drug or until initiation of another anti-cancer therapy (up to approximately 5 years)
Time frame: Days 1-21 of Cycle 1 (Cycle length = 21 days) for Arms A, C, D and E and the 28 days following the first administration of atezolizumab in Arm B
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: From treatment initiation until documented disease progression or death from any cause, whichever occurs first (up to approximately 5 years)
Time frame: From treatment initiation until documented disease progression or death from any cause, whichever occurs first (up to approximately 5 years)
Time frame: Pre-infusion (0 hour [hr]) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: From Baseline until death or disease progression, whichever occurs first (up to approximately 5 years)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr) on Cycle 1 Day 1 (cycle length = 21 or 14 days) up to approximately 5 years (detailed timeframe is provided in outcome measure description)
Time frame: Pre-infusion (0 hr), 0.5 hrs after EOI (infusion duration=90 min) on Day 1 Cycles 1 & 3 (each cycle = 21 days); EOT; every 30 days (for up to 120 days) after EOT until death or withdrawal or study closure (up to approximately 5 years)
Time frame: Pre-infusion (0 hr), 0.5 hrs after EOI (infusion duration=90 min) on Day 1 Cycles 1 & 3 (each cycle = 21 days); EOT; every 30 days (for up to 120 days) after EOT until death or withdrawal or study closure (up to approximately 5 years)
Time frame: Pre- infusion (0 hr) on Day 1 Cycle 1; end of 5-FU bolus and 2 and 12-24 hrs after end of 5-FU bolus (infusion duration = 46 hrs) on Day 1 of Cycles 1 and 3 (each cycle=14 days)
Time frame: Pre-infusion (0 hr) on Day 1 Cycle 1; 5-10 min before end of oxaliplatin infusion (infusion duration = 120 min) and 2 and 12-24 hrs after end of 5-FU bolus (infusion duration = 46 hrs) on Day 1 of Cycles 1 and 3 (each cycle=14 days)
Time frame: Pre-infusion (0 hr), 5-10 min before and 1 hr after carboplatin EOI (infusion duration=15-30 min),24 hr after atezolizumab EOI (infusion duration=90 min)on Day 1 Cycle 1; 5-10 min before and 1 hr after carboplatin EOI Day 1 Cycle 3 (each cycle=21 days)
Time frame: Pre-infusion (0 hr), 5-10 min before and 1 hr after paclitaxel EOI (infusion duration=180 min), 24 hr after atezolizumab EOI (infusion duration=90 min) on Day 1 Cycle 1; 5-10 min before and 1 hr after paclitaxel EOI on Day 1 Cycle 3 (each cycle=21 days)
Time frame: Pre-infusion (0 hr), 5-10 min before and 1 hr after pemetrexed EOI (infusion duration=10 min), 24 hr after atezolizumab EOI (infusion duration=90 min) on Day 1 Cycle 1; 5-10 min before and 1 hr after pemetrexed EOI on Day 1 Cycle 3 (each cycle = 21 days)
Time frame: Pre-infusion (0 hr), 5-10 min before and 1 hr after nab-paclitaxel EOI (infusion duration=30 min) on Day 1 of Cycles 1 and 3; 24 hr after atezolizumab EOI (infusion duration=90 min) on Day 1 Cycle 1 (each cycle=7 days)
Time frame: From Baseline up to approximately 5 years
Time frame: From Baseline up to approximately 5 years
Time frame: From first dose of study treatment until death from any cause (up to approximately 5 years)
Genentech, Inc.
Industry
A Phase Ib Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Bevacizumab and/or Chemotherapy in Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05364372
Behavior, Cancer
Tucson, Arizona, United States
View Trial DetailsNCT01445483
Brain Diseases, Brain Metastasis
Bethesda, Maryland, United States
View Trial DetailsNCT00038727
Body Weight, CVD
Rockville, Maryland, United States
View Trial DetailsNCT03556384
Brain Diseases, Cancer
La Jolla, California, United States
View Trial Details