PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy (NCT04494009) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy
South Korea110 participantsStarted 2020-09-07
Plain-language summary
This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy.
Who can participate
Age range
19 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
. Be willing and able to provide written informed consent for the trial.
. Be ≥19 years of age on the day of signing the informed consent.
. Have ECOG performance status 0-2 (Appendix 1).
. Have histologically proven esophageal squamous cell carcinoma (ESCC).
. Have demonstrated cT1b N1-3 M0 or T2-4b N0-3 M0 (8th AJCC staging system) before definitive chemoradiotherapy (Appendix 2).
. Have completed definitive concurrent chemoradiotherapy for esophageal cancer due to unresectable disease status (such as cervical esophageal cancer and T4b), medically inoperable status, or patient's refusal of undergoing surgery.
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.
. Have received fluoropyrimidine or taxane plus platinum chemotherapy (including, but not limited to fluorouracil plus cisplatin, capecitabine plus cisplatin, and paclitaxel plus carboplatin according to the institute standard of care regimens) concurrent with radiation therapy. One or two cycles of induction chemotherapy before chemoradiotherapy is allowed, but chemotherapy after concurrent chemoradiotherapy is not allowed.
. Have received a total dose of radiation of at least 50 Gy as part of concurrent chemoradiotherapy.
Exclusion criteria
. Has demonstrated disease progression while or after completion of definitive chemoradiotherapy for locally advanced ESCC.
. Has received sequential chemotherapy or chemoradiotherapy after completion of concurrent chemoradiotherapy for locally advanced ESCC.
. Has received any immunotherapy or investigational drug within 4 weeks prior to randomization.
. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy, investigational agent, or local treatment (except for stent insertion or feeding enterostomy for palliative intent) for cancer treatment.
. Any unresolved toxicities CTCAE grade ≥2 from prior therapy with the exception of alopecia, fatigue, and neuropathy.
. Has undergone major surgery within 4 weeks prior to entry into the study.
. Has an active autoimmune disease that has required systemic treatment within the 2 years prior to entry into the study (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal insufficiency of pituitary insufficiency) is not considered a form of systemic treatment and is allowed.