A Phase 2 interventional study of Nivolumab and Ipilimumab in Inoperable œsophageal Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
The main objective of the trial is to assess the feasibility and the safety of the addition of immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant chemoradiation therapy (CRT) in inoperable patients with early or locally advanced oesophageal cancer and to select the more promising experimental arm among the two possible combinations in terms of activity (based on progression free survival (PFS) at 12 months according to RECIST 1.1) for further evaluation in a phase III trial.
The secondary objectives will aim to evaluate progression-free survival, failure-free survival and overall survival and pattern of progression (including incidence of distance metastasis).
Exclusion Criteria:
All patients will receive standard fractionation radiation therapy (RT) scheme: 50Gy in 25 fractions over 5 weeks (i.e. 2Gy per fraction), concurrently with 3 cycles of 2 weeks of FOLFOX followed by 3 cycles of 2 weeks of FOLFOX without RT. Induction phase: Nivolumab IV 240 mg on days 1, 15 and 29 followed by a maintenance phase (to start on day 43) of Nivolumab IV 240 mg q2 weekly for up to 1 year.
Drug: Nivolumab · Other: Chemoradiation
Same as arm A + induction phase: Ipilimumab IV 1 mg/kg on day 1 followed by a maintenance phase (to start on day 43) of Ipilimumab IV 1 mg/kg q6 weekly for up to 1 year
Drug: Nivolumab · Drug: Ipilimumab · Other: Chemoradiation
Induction phase: Nivolumab IV 240 mg on days 1, 15 and 29 followed by a maintenance phase (to start on day 43) of Nivolumab IV 240 mg q2 weekly for up to 1 year.
Induction phase: Ipilimumab IV 1 mg/kg on day 1 followed by a maintenance phase (to start on day 43) of Ipilimumab IV 1 mg/kg q6 weekly for up to 1 year.
All patients will receive standard fractionation radiation therapy (RT) scheme: 50Gy in 25 fractions over 5 weeks (i.e. 2Gy per fraction), concurrently with 3 cycles of 2 weeks of FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, bolus fluorouracil 400 mg/m2, and infusional fluorouracil 1600 mg/m2 over 48 h), followed by 3 cycles of 2 weeks of FOLFOX without RT.
12-Month Progression-free survival using RECIST 1.1
The analysis of the 12-Month Progression-free survival rate (PFS-12) will be done when all patients achieved at least 15 months follow-up (12 months for the primary endpoint plus 100 days after the end of the protocol treatment).
Time frame: 3.8 years from first patient in
Best overall response according to RECIST 1.1
Time frame: 3.8 years from first patient in
Pattern of first cause of progression (either local relapse/progression,either regional relapse/progression, either distant metastasis)
Time frame: 3.8 years from first patient in
Progression-free survival using RECIST 1.1
Time frame: 3.8 years from first patient in
Failure-free survival
Time frame: 3.8 years from first patient in
Overall survival
Time frame: 3.8 years from first patient in
Percentage of patients receiving the planned chemoradiation
Time frame: 3.8 years from first patient in
Relative dose intensity of oxaliplatinum
The dose intensity and relative dose intensity of treatments will be presented by drug and by treatment arm using median, range and interquartile range.
Time frame: 3.8 years from first patient in
Relative dose intensity of 5FU
The dose intensity and relative dose intensity of treatments will be presented by drug and by treatment arm using median, range and interquartile range.
Time frame: 3.8 years from first patient in
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC