TriangleNCT02569242 · CITED IN SOURCE DOCUMENTS
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2022-07-06
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Men \& women ≥20 years of age * Histologically confirmed unresectable advanced or recurrent esophageal cancer * Refractory to or intolerant of standard therapy * ECOG Performance Status score 0 or 1 * A life expectancy of at least 3 months Exclusion Criteria: * Current or past history of severe hypersensitivity to any other antibody products * Patients with multiple primary cancers * Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment * Patients with active, known or suspected autoimmune disease
- healthy Volunteers
- false
- minimum Age
- 20 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- intervention Names
- Drug: Nivolumab
- label
- Nivolumab Arm
- type
- EXPERIMENTAL
- description
- Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- intervention Names
- Drug: Docetaxel/Paclitaxel
- label
- Active Comparator Arm （Docetaxel/Paclitaxel）
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Nivolumab Arm
- name
- Nivolumab
- type
- DRUG
- arm Group Labels
- Active Comparator Arm （Docetaxel/Paclitaxel）
- name
- Docetaxel/Paclitaxel
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 419
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Overall Survival
- time Frame
- ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
- secondary Outcomes
- description
- Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
- measure
- Progression-free Survival
- time Frame
- ("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.
- description
- Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
- measure
- Duration of Response
- time Frame
- ("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.
Full study description
- brief Summary
- The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
Source references
- references
- citation
- Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30.
- pmid
- 31582355
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- is a description of the efficacy results of the adequate and well-controlled study of intravenous nivolumab in this ESCC population. ATTRACTION-3 ATTRACTION-3 (NCT02569242) was a multicenter, randomized (1:1), active-controlled, open‑label trial in patients with unresectable advanced, recurrent, or metastatic ESCC, who were refra
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- mate-648-A opdivo-pfs-checkmate-648-B Previously Treated Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) ATTRACTION-3 (NCT02569242) was a multicenter, randomized (1:1), active-controlled, open-label trial in patients with unresectable advanced, recurrent, or metastatic ESCC, who were refra
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- f patients who received chemotherapy.</li><li>Patients in this study had not received prior immunotherapy.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT02569242">ATTRACTION-3</a> study (NCT02569242), a multicenter, randomized, open-label, phase III trial, included 419 patients with squamous or adenosquamous esophageal
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- Esophageal Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: March 21, 2025
- datetime
- 2025-03-21T12:00:00Z
- display
- March 21, 2025
Preserved source evidence · Not medical advice