A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Conditions

• Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nab-Paclitaxel — DRUG
  Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
• Gemcitabine — DRUG
  Gemcitabine will be administered as per the schedule specified in the respective arm.
• Oxaliplatin — DRUG
  Oxaliplatin will be administered as per the schedule specified in the respective arm.
• Leucovorin — DRUG
  Leucovorin will be administered as per the schedule specified in the respective arm.
• Fluorouracil — DRUG
  Fluorouracil will be administered as per the schedule specified in the respective arm.
• Atezolizumab — DRUG
  Atezolizumab will be administered as per the schedule specified in the respective arm.
• Cobimetinib — DRUG
  Cobimetinib will be administered as per the schedule specified in the respective arm.
• PEGPH20 — DRUG
  PEGPH20 will be administered as per the schedule specified in the respective arm.
• BL-8040 — DRUG
  BL-8040 will be administered as per the schedule specified in the respective arm.
• Selicrelumab — DRUG
  Selicrelumab will be administered as per the schedule specified in the respective arm.
• Bevacizumab — DRUG
  Bevacizumab will be administered as per the schedule specified in the respective arm.
• RO6874281 — DRUG
  RO6874281 will be administered as per the schedule specified in the respective arm
• AB928 — DRUG
  AB928 will be administered as per the schedule specified in the respective arm.
• Tiragolumab — DRUG
  Tiragolumab will be administered as per the schedule specified in the respective arm.
• Tocilizumab — DRUG
  Tocilizumab will be administered as per the schedule specified in the respective arm.

Study Details

A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.

Key Dates

Start date

Jul 5, 2017

Status verified

Nov 2025

Primary completion

Feb 27, 2025

Completion

Feb 27, 2025

Study Design

Enrollment

341 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)
  Cohort 1: Participants will receive Nab-Paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle. Participants in the Cohort 1 control arm who experience disease progression will be given the option of enrolling into Cohort 2 (if open for enrollment), provided they meet eligibility criteria.
• Experimental: Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
  Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Selicrelumab 16 mg subcutaneous injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each 28-day cycle.
• Experimental: Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
  Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Bevacizumab 10 mg/kg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
• Experimental: Cohort 1: Atezolizumab + Chemotherapy + AB928
  Cohort 1: Participant will receive AB928 150 mg orally once daily on Days 1 to 28 of each 28 day cycle; Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
• Experimental: Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
  Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Tiragolumab 420 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
• Experimental: Cohort 2: Atezolizumab + Cobimetinib
  Cohort 2: Participants will receive Cobimetinib 60 milligrams (mg) once daily orally on Days 1-21 of each 28-day cycle; and Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arm is open for enrollment.
• Experimental: Cohort 2: Atezolizumab + PEGPH20
  Cohort 2: Participants will receive PEGPH20 3 micrograms per kilogram (mcg/kg) IV infusion on Days 1, 8 and 15 of each 21-day cycle; and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
• Experimental: Cohort 2: Atezolizumab + BL-8040
  Cohort 2: Participants will receive BL-8040 1.25 milligrams per kilogram (mg/kg) subcutaneously (SC) on Days 1-5 of the first week, followed by combination treatment consisting of BL-8040 1.25 mg/kg SC three times a week on non-consecutive days and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
• Experimental: Cohort 2: Atezolizumab + RO6874281 every 2 weeks
  Cohort 2: Participants will receive Atezolizumab 840 mg IV infusion on days 1 and 15 of each 28 day cycle; RO6874281 will be administered 10 mg by IV infusion on day 1 and 15 mg on days 8, 15, and 22 for cycle 1 (28 day cycle). RO6874281 will be administered 15 mg by IV infusion on days 1 and 15 of each subsequent 28 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
• Experimental: Cohort 2: Atezolizumab + RO6874281 every 3 weeks
  Cohort 2: Participants will receive Atezolizumab 1200 mg IV infusion on Day 1 of each 21 day cycle; and RO6874281 10 mg by IV infusion on day 1 of each 21 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
• Active Comparator: Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
  Cohort 2: Participants who progressed on a prior fluoropyrimidine-based regimen will receive Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle. Participants who progressed on a prior gemcitabine-based regimen will receive 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). Participants will receive Oxaliplatin 85 mg/m\^2 IV on Days 1 and 15 of each 28 day cycle; Leucovorin 400 mg/m\^2 IV on Days 1 and 15 of each 28 day cycle; Fluorouracil 400 mg/m\^2 IV push on Days 1 and 15 of each 28 day cycle; and Fluorouracil 2400 mg/m\^2 IV continuous infusion over 46 hours on Days 1 and 2 and on Days 15 and 16 of each 28 day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
• Experimental: Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
  Cohort 1: Participants will receive Tocilizumab 8 mg/kg IV infusion on Day 1 of each 28 day cycle; Atezolizumab 1680 mg IV infusion on Day 1 of each 28 day cycle; Nab-paclitaxel 125 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.

Primary Outcome Measure

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Up to 33.3 months ]

Locations (12)

Related coverage on Hipa.ai

• Atezolizumab Combinations Show Varied ORR in Metastatic Pancreatic Cancer
  Atezolizumab · Nov 21, 2025 · ClinicalTrials.gov

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