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Chemotherapy
Immunotherapy Combinations for Esophageal 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
Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus in locally advanced or metastatic disease;
Age >/= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to death from any cause (up to approximately 3-6 years)
Awards & highlights
Study Summary
This trial is designed to study the safety and effectiveness of immunotherapy-based treatment combinations in patients with gastric or esophageal cancer.
Who is the study for?
Adults with advanced gastric or gastroesophageal junction cancer, or esophageal cancer who have not had certain treatments. They must be in good physical condition (ECOG 0-1), expect to live at least 3 months, and agree to use contraception. Excluded are those with uncontrolled hypertension, recent severe infections, significant heart disease, autoimmune diseases, HIV/HBV/HCV infection, CNS metastases risk factors for bleeding disorders.Check my eligibility
What is being tested?
The trial is testing combinations of immunotherapy and chemotherapy in patients with advanced gastric or esophageal cancers. It includes drugs like Atezolizumab and Tiragolumab alongside standard chemotherapies such as Cisplatin and Paclitaxel. Patients will be randomly assigned to different treatment groups.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug administration process itself, fatigue, gastrointestinal issues like nausea or diarrhea, blood-related problems including anemia or clotting issues, increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My esophagus cancer is confirmed and is either advanced or has spread.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My esophageal cancer is confirmed and has spread or is very advanced.
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I agree to not have sex or use birth control and not donate sperm.
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My gastric cancer is HER2-negative.
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I can take care of myself and am up and about more than half of my waking hours.
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I am able to care for myself and perform daily activities.
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I am fully active or can carry out light work.
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My cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to death from any cause (up to approximately 3-6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to death from any cause (up to approximately 3-6 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
For Arm 1L-A : Percentage of Participants with Serious and Non-serious Treatment-related 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)
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
Duration of Response, as Determined by Investigator According to RECIST v1.1
Overall Survival (OS)
Percentage of Participants Who Are Alive at Month 6 and at Month 12
+10 moreTrial Design
12Treatment groups
Experimental Treatment
Active Control
Group I: 2L-4: Atezo + Linagliptin (Gastric Cancer)Experimental Treatment2 Interventions
Participants in the 2L-4 Gastric Cancer arm received atezolizumab in combination with linagliptin. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
Group II: 2L-3: Atezo + BL-8040 (Gastric Cancer)Experimental Treatment2 Interventions
Participants in the 2L-3 Gastric Cancer arm received atezolizumab in combination with BL-8040. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
Group III: 2L-2: Atezo + PEGPH20 (Gastric Cancer)Experimental Treatment2 Interventions
Participants in the 2L-2 Gastric Cancer arm received atezolizumab in combination with PEGylated recombinant human hyaluronidase (PEGPH20). Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
Group IV: 2L-1: Atezo + Cobi (Gastric Cancer)Experimental Treatment2 Interventions
Participants in the 2L-1 Gastric Cancer arm received atezolizumab in combination with cobimetinib. Enrollment completed as of October 2019.
Group V: 1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer)Experimental Treatment5 Interventions
Participants in the 1L-A Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab plus cobimetinib. No longer enrolling participants as of June 2018.
Group VI: 1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer)Experimental Treatment5 Interventions
Participants in the 1L-A2 Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab during cycles 1 and 2 followed by atezolizumab plus cobimetinib during cycles 3 and beyond. No longer enrolling participants as of June 2018.
Group VII: 1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort)Experimental Treatment2 Interventions
Participants in the 1L-3 Esophageal Cancer arm will receive atezolizumab + tiragolumab treatment. Participants from the cisplatin + 5-FU esophageal cancer cohort arm may be permitted to enroll in this arm if they progress after receiving chemotherapy.
Group VIII: 1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort)Experimental Treatment3 Interventions
Participants in the 1L-2 Esophageal Cancer arm will receive atezolizumab in combination with chemotherapy.
Group IX: 1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort)Experimental Treatment4 Interventions
Participants in the 1L-1 Esophageal Cancer arm will receive atezolizumab in combination with tiragolumab and chemotherapy.
Group X: 2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer)Active Control2 Interventions
Participants in the 2L Gastric Cancer Control arm received ramucirumab plus paclitaxel. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
Group XI: 1L-Control: mFOLFOX6 (Gastric Cancer)Active Control3 Interventions
Participants in the 1L Gastric Cancer Control arm will receive modified FOLFOX6 (mFOLFOX6) treatment consisting of 5-fluorouracil (5-FU), leucovorin (folinic acid), and oxaliplatin. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria. No longer enrolling participants as of June 2018.
Group XII: 1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort)Active Control2 Interventions
Participants in the 1L-Control Eophageal Cancer arm will receive chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~2660
BL-8040
2014
Completed Phase 2
~220
5-Fluorouracil (5-FU)
2003
Completed Phase 3
~5560
Oxaliplatin
2011
Completed Phase 4
~2560
Cisplatin
2013
Completed Phase 3
~1940
Atezolizumab
2017
Completed Phase 3
~5860
Leucovorin
2005
Completed Phase 4
~5730
Tiragolumab
2020
Completed Phase 2
~350
Linagliptin
2010
Completed Phase 4
~19930
Find a Location
Who is running the clinical trial?
BioLineRx, Ltd.Industry Sponsor
21 Previous Clinical Trials
1,710 Total Patients Enrolled
Halozyme TherapeuticsIndustry Sponsor
45 Previous Clinical Trials
2,934 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,644 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is not gastric cancer.I haven't had cancer other than in my stomach or where my stomach meets my esophagus in the last 2 years.I have brain metastases that are untreated or getting worse.I have only had esophageal cancer or a low-risk cancer in the past 2 years.I agree to either not have sex or use birth control, and not donate sperm during the trial.My blood and organs are functioning well.I haven't had any serious wounds, ulcers, or fractures in the last 28 days.I have not had any serious gut issues like perforations or abnormal connections in the last 6 months.I have a history of serious bowel problems or surgeries.My blood pressure is high (over 150/90) despite taking medication.I am on long-term medication for pain or inflammation that affects blood clotting.I have not had a severe infection in the last 4 weeks.I have a serious heart condition.I have esophageal cancer with no prior systemic treatment, or it spread 6+ months after my last chemo.My cancer is advanced and cannot be surgically removed, and it's either in my stomach or where my stomach meets my esophagus.I am 18 years old or older.I am fully active or can carry out light work.My esophageal cancer is confirmed and has spread or is very advanced.My esophagus cancer is confirmed and is either advanced or has spread.I have esophageal cancer with no prior systemic treatment, or it spread 6+ months after my last chemo. My cancer does not show HER2.I have high calcium levels in my blood that aren't controlled or cause symptoms.I have a history of specific lung conditions or signs of lung inflammation on a recent CT scan.I have a condition that causes significant bleeding.I have had a previous transplant of stem cells or an organ.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I am currently on blood thinners like warfarin or heparin for treatment.I do not have esophageal cancer.I am at high risk for developing an esophageal fistula.I have active tuberculosis.I haven't had major heart problems or unstable heart conditions in the last 3 months.I have been diagnosed with gastric cancer.I agree to not have sex or use birth control and not donate sperm.My gastric cancer is HER2-negative.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I am able to care for myself and perform daily activities.I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.My condition is esophageal cancer.I agree to either not have sex or use birth control, and not donate sperm.I am fully active or can carry out light work.I have had cancer spread to the lining of my brain and spinal cord.My gastric cancer is HER2-negative.My recent blood and organ function tests are within normal ranges.I agree to either not have sex or use birth control, and not donate sperm while on treatment.My blood and organs are functioning well.I have brain metastases that are untreated or getting worse.My cancer is advanced and cannot be removed by surgery.I can provide a tumor sample for testing.My recent blood tests show my organs are functioning well.I can provide a tumor sample for PD-L1 and TIGIT testing.
Research Study Groups:
This trial has the following groups:- Group 1: 2L-4: Atezo + Linagliptin (Gastric Cancer)
- Group 2: 2L-3: Atezo + BL-8040 (Gastric Cancer)
- Group 3: 1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer)
- Group 4: 1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer)
- Group 5: 1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort)
- Group 6: 1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort)
- Group 7: 2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer)
- Group 8: 1L-Control: mFOLFOX6 (Gastric Cancer)
- Group 9: 1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort)
- Group 10: 1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort)
- Group 11: 2L-2: Atezo + PEGPH20 (Gastric Cancer)
- Group 12: 2L-1: Atezo + Cobi (Gastric Cancer)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Esophageal Cancer Patient Testimony for trial: Trial Name: NCT03281369 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers are presently engaging in this clinical trial?
"This medical investigation is being conducted at several sites including: Froedtert and The Medical College of Wisconsin in Milwaukee, UCLA Jonsson Comprehensive Cancer Center in Los Angeles, as well University of Kentucky in Lexington."
Answered by AI
To what extent is participation in this research endeavor being sought after?
"In order to execute this clinical trial, 410 eligible patients need to be recruited. The two main sites for recruitment are Froedtert and The Medical College of Wisconsin in Milwaukee, WI and UCLA Jonsson Comprehensive Cancer Center in Los Angeles, CA."
Answered by AI
Is this research initiative currently enrolling participants?
"Yes, that is accurate. The information on clinicaltrials.gov reveals that this experiment, which was initially announced on October 13th 2017, is currently in the process of recruitment and requires 410 subjects from 5 distinct locations."
Answered by AI
For what ailments is Atezolizumab regularly prescribed?
"Atezolizumab is a renowned therapeutic agent for metastatic bladder cancer and has been tested to treat other malignancies such as inflammatory breast cancer (IBC), advanced testicular cancer, and small cell lung cancer (SCLC)."
Answered by AI
What further investigations have been undertaken concerning the efficacy of Atezolizumab?
"Currently, we observe 2087 active studies concerning Atezolizumab, with 621 trials in their terminal stage. As the majority of these research efforts are conducted at sites in Guangzhou, Guangdong province, there exists a total of 109624 locations that are engaged in tests for this medication."
Answered by AI
Who else is applying?
What site did they apply to?
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am hoping this clinical trial will help to make my health better and also contribute to medicine and treatment for Cancer.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
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