Trial · NCT04458909
Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
NCT04458909, Phase 3, Terminated, National Cancer Institute (NCI); results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer. Trials, record NCT04458909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04458909
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
- NCT number
- NCT04458909
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Metastatic Nasopharyngeal Nonkeratinizing Carcinoma, Metastatic Nasopharyngeal Undifferentiated Carcinoma, Nasopharyngeal Nonkeratinizing Carcinoma, Recurrent Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Nasopharyngeal Undifferentiated Carcinoma, Stage IV Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVB Nasopharyngeal Carcinoma AJCC v8
- Interventions
- Carboplatin, Cisplatin, Gemcitabine, Nivolumab, Questionnaire Administration
- First posted
- 2020-07-07
- Last updated
- 2025-10-03
- Results first posted
- 2024-09-19
- Limitations and caveats
This study stopped accrual early at 15 participants of the 316 planned, due to published results of two other studies resolving the study question (NCT03707509, NCT03581786). As less than 5% of the sample size was accrued, no statistical testing was done.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years. | Failure is death from any cause. Survival rates were to be estimated using the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur after 200 deaths have been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive at time of study termination is reported. |
| Secondary | Locoregional Failure | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Locoregional failure is defined as first evidence of local or regional progression, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and deaths from other causes were considered competing risks. Progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance or recurrence of any locoregional lesions is also considered progression. Failure rates were to be estimated using the cumulative incidence method and arms were to be compared using the cause-specific log-rank test. Analysis was to occur after 200 deaths. Given the small number of participants due to early study closure, only the number of patients with locoregional failure is reported. |
| Secondary | Distant Metastases | Randomization to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Distant failure is defined as first evidence of distant metastasis; locoregional failure and all deaths were to be considered competing risks. Distant failure rates were to be estimated using the cumulative incidence method and arms were to be compared using the cause-specific log-rank test. Analysis was to occur after 200 deaths. Given the small number of participants due to early study closure, only the number of patients with distant failure is reported. |
| Secondary | Progression-free Survival (PFS) | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Failure is defined as local, regional, or distant disease progression, or death from any cause. Progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance or recurrence of any lesions is also considered progression. Failure rates were to be estimated using the Kaplan-Meier method and arms were to be compared using the log-rank test. Analysis was to occur after 200 deaths. Given the small number of participants due to early study closure, only the number of patients alive without progression is reported. |
| Secondary | Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Baseline through end of cycle 6 (each cycle is 21 days) | CT/MRI of nasopharynx and neck or chest CT at baseline and through the end of cycle 6 are compared to determine tumor response. Per RECIST 1.1: * Complete response: * Disappearance of all lesions and pathologic lymph nodes * Partial response: * 30% decrease sum of the longest diameters * No new lesions * No progression of non-target lesions |
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events (AEs) | Baseline to the date of last follow-up. Maximum follow-up time was 2.3 years. | Common Terminology Criteria for Adverse Events (CTCAE) version 5 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Counts of participants with any grade 3 or higher adverse event are reported. Adverse events of any attribution are included. |
| Secondary | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline | Baseline | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This study collects PRO-CTCAE data on sixteen symptomatic adverse events (AEs), asking about experience over the last seven days. Worst severity of the given symptom was collected for 14 items (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Any presence of the symptom was collected for 2 items (present/absent). For each symptom, the row label indicates whether severity score ≥ 3 or presence is reported. |
| Secondary | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 | End of cycle 6 (each cycle is 21 days for the first six cycles) | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This study collects PRO-CTCAE data on sixteen symptomatic adverse events (AEs), asking about experience over the last seven days. Worst severity of the given symptom was collected for 14 items (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Any presence of the symptom was collected for 2 items (present/absent). For each symptom, the row label indicates whether severity score ≥ 3 or presence is reported. |
| Secondary | Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | End of cycle 6 (each cycle is 21 days) | Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). |
| Secondary | Multidimensional Fatigue Inventory (MFI)-20 Total Score | End of cycle 6 (each cycle is 21 days) | The MFI-20 is a 20-item self-report instrument measuring fatigue with the total score ranging from 20 to 100 and a higher score indicating more fatigue. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Locoregional Failure | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Metastases | Randomization to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Baseline through end of cycle 6 (each cycle is 21 days) | Randomized participants with scans at baseline and end of cycle 6 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events (AEs) | Baseline to the date of last follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline | Baseline | Randomized participants with any PRO-CTCAE data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 | End of cycle 6 (each cycle is 21 days for the first six cycles) | Randomized participants with any PRO-CTCAE data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | End of cycle 6 (each cycle is 21 days) | Randomized participants with cycle 6 data | score on a scale | MEAN |
| SECONDARY | Multidimensional Fatigue Inventory (MFI)-20 Total Score | End of cycle 6 (each cycle is 21 days) | Randomized participants with MFI data at cycle 6 | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 8 | Participants | ||
| Overall Survival (OS) | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 | Participants | ||
| Locoregional Failure | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 6 | Participants | ||
| Locoregional Failure | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 | Participants | ||
| Distant Metastases | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 2 | Participants | ||
| Distant Metastases | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 1 | Participants | ||
| Progression-free Survival (PFS) | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 3 | Participants | ||
| Progression-free Survival (PFS) | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 3 | Participants | ||
| Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 4 | Participants | ||
| Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 11 | |
| Overall Study | STARTED | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 | |
| Overall Study | Started Protocol Treatment | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 11 | |
| Overall Study | Started Protocol Treatment | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 | |
| Overall Study | COMPLETED | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 11 | |
| Overall Study | COMPLETED | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 | |
| Overall Study | NOT COMPLETED | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 |
Source ClinicalTrials.gov
Adverse events226
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 5 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 2 | 4 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 1 | 11 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 2 | 4 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 2 | 11 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 | 4 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 0 | 11 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 1 | 4 | |
| other | Vertigo | Ear and labyrinth disorders | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 1 | 11 | |
| other | Vertigo | Ear and labyrinth disorders | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 | 4 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 3 | 11 |
| Total, all-cause mortality | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 0 | 4 |
| Total, other adverse events | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 11 | 11 |
| Total, other adverse events | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 | 4 |
| Total, serious adverse events | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 10 | 11 |
| Total, serious adverse events | Arm II (Gemcitabine, Cisplatin / Carboplatin) | 2 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Overall Survival (OS) | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Distant Metastases | Trial comparisons |
Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Progression-free Survival (PFS) | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Number of Participants With Grade 3 or Higher Adverse Events (AEs) | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Locoregional Failure | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): deaths from any cause | Trial comparisons |
| Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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