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Immunotherapy Combination

Immunotherapy Combinations for Pancreatic Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing

Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to death from any cause (up to approximately 7-9 years)

Awards & highlights

Study Summary

This trial is testing different combinations of immunotherapy drugs to see which are safe and effective against pancreatic cancer. It will enroll two groups of patients: those who have not received any prior treatment for their cancer, and those who have received one line of treatment. Patients will be assigned to different treatment arms within each group.

Who is the study for?

This trial is for adults with metastatic pancreatic ductal adenocarcinoma. Cohort 1 includes those who haven't had systemic treatment, while Cohort 2 has had one prior treatment but the disease progressed. Participants need measurable disease, good performance status (able to carry out daily activities), and a life expectancy of at least 3 months. They must be willing to use contraception and provide tumor samples.Check my eligibility

What is being tested?

The study tests combinations of immunotherapy drugs like RO6874281, AB928, Bevacizumab, among others in two groups: one untreated for cancer and another after first-line therapy failure. It aims to evaluate safety, tolerability and initial effectiveness against this type of pancreatic cancer.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs, infusion-related symptoms such as fever or chills, fatigue, digestive issues like nausea or diarrhea, blood abnormalities leading to increased risk of infections or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a sample of my tumor for PD-L1 testing.

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My cancer is a type of pancreatic cancer confirmed by lab tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor can be easily reached for a biopsy.

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I have pancreatic cancer and haven't received any systemic treatment for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to death from any cause (up to approximately 7-9 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to death from any cause (up to approximately 7-9 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to death from any cause (up to approximately 7-9 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Adverse Events (AEs)

Percentage of Participants With Objective Response, as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

Secondary outcome measures

Duration of Response, as Determined by Investigator According to RECIST v1.1

Overall Survival

Percentage of Participants With Disease Control, as Determined by Investigator According to RECIST v1.1

+2 more

Trial Design

12Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: Atezolizumab + RO6874281 every 3 weeksExperimental Treatment2 Interventions

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.

Group II: Cohort 2: Atezolizumab + RO6874281 every 2 weeksExperimental Treatment2 Interventions

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.

Group III: Cohort 2: Atezolizumab + PEGPH20Experimental Treatment2 Interventions

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.

Group IV: Cohort 2: Atezolizumab + CobimetinibExperimental Treatment2 Interventions

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.

Group V: Cohort 2: Atezolizumab + BL-8040Experimental Treatment2 Interventions

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.

Group VI: Cohort 1: Atezolizumab + Chemotherapy + TocilizumabExperimental Treatment4 Interventions

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.

Group VII: Cohort 1: Atezolizumab + Chemotherapy + TiragolumabExperimental Treatment4 Interventions

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.

Group VIII: Cohort 1: Atezolizumab + Chemotherapy + SelicrelumabExperimental Treatment4 Interventions

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.

Group IX: Cohort 1: Atezolizumab + Chemotherapy + BevacizumabExperimental Treatment4 Interventions

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.

Group X: Cohort 1: Atezolizumab + Chemotherapy + AB928Experimental Treatment4 Interventions

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.

Group XI: Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)Active Control2 Interventions

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.

Group XII: Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobimetinib

2017

Completed Phase 3

~2660

PEGPH20

2014

Completed Phase 2

~540

Tiragolumab

2020

Completed Phase 2

~350

Atezolizumab

2017

Completed Phase 3

~5860

BL-8040

2014

Completed Phase 2

~220

Selicrelumab

2014

Completed Phase 1

~240

Bevacizumab

2013

Completed Phase 4

~5280

RO6874281

2015

Completed Phase 1

~290

Tocilizumab

2012

Completed Phase 4

~1840

Nab-Paclitaxel

2014

Completed Phase 3

~4340

Gemcitabine

2017

Completed Phase 3

~2070

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,714 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,162 Total Patients Enrolled

Media Library

Atezolizumab + AB928 (Immunotherapy Combination) Clinical Trial Eligibility Overview. Trial Name: NCT03193190 — Phase 1 & 2

Pancreatic Adenocarcinoma Research Study Groups: Cohort 2: Atezolizumab + PEGPH20, Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab, Cohort 1: Atezolizumab + Chemotherapy + AB928, Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab, Cohort 2: Atezolizumab + RO6874281 every 3 weeks, Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab, Cohort 1: Control (Nab-Paclitaxel and Gemcitabine), Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6), Cohort 2: Atezolizumab + BL-8040, Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab, Cohort 2: Atezolizumab + Cobimetinib, Cohort 2: Atezolizumab + RO6874281 every 2 weeks

Pancreatic Adenocarcinoma Clinical Trial 2023: Atezolizumab + AB928 Highlights & Side Effects. Trial Name: NCT03193190 — Phase 1 & 2

Atezolizumab + AB928 (Immunotherapy Combination) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03193190 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What findings have other researchers uncovered about Bevacizumab?

"Bevacizumab was first studied in the year 1997 at City of Hope Comprehensive Cancer Center. A total of 3683 completed studies have been conducted on this medication. As of now, there are 2145 active clinical trials being performed across the globe; a large number hail from Chicago, Illinois."

Answered by AI

What conditions does Bevacizumab usually treat?

"Bevacizumab is a common treatment for unresectable melanoma. This medication can also target other conditions, such as malignant neoplasms, non-small cell lung carcinoma, and rectal carcinoma."

Answered by AI

Could you give me an overview of how many people are participating in this clinical trial?

"In order to run this clinical trial, 290 eligible patients must agree to participate. These individuals can be located at Uni of Chicago Medical Center in Room M454 of Chicago, Illinois or Morristown Medical Center in Morristown, New jersey."

Answered by AI

In how many different hospitals is this trial being run?

"There are 8 sites that have been approved by the IRB for this clinical trial. They are as follows: Uni of Chicago Medical Center; Room M454 in Chicago, Morristown Medical Center in Morristown, and Columbia University in New york."

Answered by AI

Is this research still recruiting new participants?

"The website clinicaltrials.gov says that this study is still looking for patients to enroll. The trial was originally posted on July 5th, 2017 and updated less than a month ago on November 1st, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03193190.

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