Atezolizumab for Adenocarcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Georgetown Lombardi Comprehensive Cancer Center, Washington, United States
Adenocarcinoma+7 More
Atezolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall bladder adenocarcinomas) diagnosed with histologically confirmed GI cancers. These patients will have already completed all Standard of Care (SOC) treatments (including neoadjuvant, surgery, local therapies, and/or adjuvant therapy as applicable), as defined by the treating primary physician or research team, with curative intent but have a positive SignateraTM tumor-informed ctDNA test and NED radiographically by standard imaging within 28 days prior to enrollment and within 1 year of completing all curative-intent therapy. All patients will be treated with intravenous (IV) atezolizumab 1200 mg IV and bevacizumab 15 mg/kg on Day 1 of 21-day cycles until disease recurrence, ctDNA POD, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month total duration of study therapy. Atezolizumab and bevacizumab drug will be provided.

Eligible Conditions

  • Adenocarcinoma
  • Rectal Adenocarcinoma
  • Liver carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: 12 months

12 months
Rate of Enrollment
Rates of SignateraTM ctDNA positive Patient identification
Reasons for failure of enrollment
Toxicity by CTCAE v5.0 criteria
Week 12
Rate of ctDNA Complete Response (CR)
Rate of ctDNA Partial Response (PR)
Rate of ctDNA Progression of Disease (POD) or Clinical/radiographic Relapse

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Atezolizumab plus Bevacizumab
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Atezolizumab · No Placebo Group · Phase 3

Atezolizumab plus BevacizumabExperimental Group · 2 Interventions: Bevacizumab, Atezolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~4030
Atezolizumab
2015
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Georgetown Lombardi Comprehensive Cancer Center · Washington, United States
Photo of washington 1Photo of washington 2Photo of washington 3
2020First Recorded Clinical Trial
2 TrialsResearching Adenocarcinoma
22 CompletedClinical Trials

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,482 Previous Clinical Trials
563,325 Total Patients Enrolled
17 Trials studying Adenocarcinoma
3,394 Patients Enrolled for Adenocarcinoma
Natera, Inc.Industry Sponsor
40 Previous Clinical Trials
43,024 Total Patients Enrolled
2 Trials studying Adenocarcinoma
42 Patients Enrolled for Adenocarcinoma
Georgetown UniversityLead Sponsor
315 Previous Clinical Trials
120,805 Total Patients Enrolled
3 Trials studying Adenocarcinoma
71 Patients Enrolled for Adenocarcinoma
John L. Marshall, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
24 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years of age to participate in this study.
You are able to comply with the study protocol.
You have a tumor-specific ctDNA test with a positive result (any mean tumor molecule/mL) drawn within 1 year of completing all curative-intent treatment and within 28 days prior to enrollment.
You have been diagnosed with any stage disease (including localized and metastatic disease) that was felt to have already been treated completely with curative-intent per investigator's, primary physician's, or research team's judgement.
You have no evidence of disease on standard imaging (chest, abdomen, and pelvis captured by CT chest and CT or MRI of abdomen and pelvis) per investigator assessment within 28 days prior to enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.