Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adeno… (NCT03604991) | Clinical Trial Compass
SuspendedPhase 2/3
Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
Stopped: End of Initial Phase of Multi-phase protocol
United States278 participantsStarted 2019-05-03
Plain-language summary
This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* STEP 1 RANDOMIZATION: Patients must be age \>= 18 years
* STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
* STEP 1 RANDOMIZATION: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* STEP 1 RANDOMIZATION: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy
* STEP 1 RANDOMIZATION: Absolute neutrophil count \>= 1,500/mcL (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Platelets \>= 100,000/mcL (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Serum creatinine =\< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Hemoglobin (Hgb) \>= 9 g/dL (within less than or equal to 14 days prior to randomization)
* STEP 1 RANDOMIZATION: Leukocytes \>= 3,000/mm\^3 (within less th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic complete response (Step I)
Timeframe: Up to 5 weeks
2
Disease-free survival (DFS) (Step 2)
Timeframe: From the adjuvant treatment randomization assessed for up to 7 years