Trial Outcomes & Findings for 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 NCT04458909)

Last Updated: 2025-10-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years.

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) Gemcitabine and cisplatin or carboplatin as in Arm I.
Overall Study STARTED	11	4
Overall Study Started Protocol Treatment	11	4
Overall Study COMPLETED	11	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.	Total n=15 Participants Total of all reporting groups
Age, Customized ≤ 49 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 50 - 59 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 60 - 69 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized ≥ 70 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years.

Population: Randomized participants

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Overall Survival (OS)	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Population: Randomized participants

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Locoregional Failure	6 Participants	0 Participants

SECONDARY outcome

Timeframe: Randomization to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Population: Randomized participants

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Distant Metastases	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Population: Randomized participants

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Progression-free Survival (PFS)	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline through end of cycle 6 (each cycle is 21 days)

Population: Randomized participants with scans at baseline and end of cycle 6

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

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
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	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to the date of last follow-up. Maximum follow-up time was 2.3 years.

Population: Randomized participants

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Number of Participants With Grade 3 or Higher Adverse Events (AEs)	10 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Randomized participants with any PRO-CTCAE data

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=9 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=3 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Sad (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Dry mouth (severity grade 3+)	1 Participants	1 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Difficulty swallowing (severity grade 3+)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Voice quality changes (presence)	2 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Mouth/throat sore (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Taste changes (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Abdominal pain (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Heart palpitations (severity grade 3+)	0 Participants	1 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Rash (presence)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Itching (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Numbness & tingling (severity grade 3+	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Blurred vision (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Ringing in ears (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Concentration (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Memory (severity grade 3+)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline Headache (severity grade 3+)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of cycle 6 (each cycle is 21 days for the first six cycles)

Population: Randomized participants with any PRO-CTCAE data

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=9 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=3 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Dry mouth (severity grade 3+)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Difficulty swallowing (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Voice quality changes (presence)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Mouth/throat sore (severity grade 3+)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Taste changes (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Abdominal pain (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Heart palpitations (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Rash (presence)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Itching (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Numbness & tingling (severity grade 3+	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Blurred vision (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Ringing in ears (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Concentration (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Memory (severity grade 3+)	1 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Headache (severity grade 3+)	0 Participants	0 Participants
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 Sad (severity grade 3+)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of cycle 6 (each cycle is 21 days)

Population: Randomized participants with cycle 6 data

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).

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=8 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=3 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	63.9 score on a scale Standard Error 9.6	75.0 score on a scale Standard Error 4.8

SECONDARY outcome

Timeframe: End of cycle 6 (each cycle is 21 days)

Population: Randomized participants with MFI data at cycle 6

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.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=8 Participants Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=3 Participants Gemcitabine and cisplatin or carboplatin as in Arm I.
Multidimensional Fatigue Inventory (MFI)-20 Total Score	61.6 score on a scale Standard Error 4.4	72.7 score on a scale Standard Error 7.8

SECONDARY outcome

Timeframe: Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Population: No assays were performed, and no data were collected for this outcome measure.

This study hypothesizes that the use of PD-L1 expression based on the TPS or CPS may be useful in identifying those patients who are more likely to benefit from treatment with PD-1 inhibitor in combination with chemotherapy. This study will explore a range of CPS and TPS scores.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of cycle 6 (each cycle is 21 days)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 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. Change is calculated as later value minus baseline value such that a negative change indicates decreased fatigue.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From randomization to last follow-up, assessed up to 8 years

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin)

Serious events: 10 serious events

Other events: 11 other events

Deaths: 3 deaths

Arm II (Gemcitabine, Cisplatin / Carboplatin)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) n=11 participants at risk Six cycles (3 weeks each): * Nivolumab 360 mg fixed dose IV over 30 minutes on day 1. * Cisplatin 80 mg/m\^2 IV over 30-60 minutes or carboplatin AUC of 5 on day 1. * Gemcitabine 1000 mg/m\^2 in IV over 30 minutes on days 1 and 8. Followed by maintenance therapy for up to 24 cycles (4 weeks each): * Nivolumab 480 mg fixed dose IV over 30 minutes on day 1.	Arm II (Gemcitabine, Cisplatin / Carboplatin) n=4 participants at risk Gemcitabine and cisplatin or carboplatin as in Arm I.
Blood and lymphatic system disorders Anemia	45.5% 5/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Gastrointestinal disorders Dysphagia	18.2% 2/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Investigations Alanine aminotransferase increased	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	25.0% 1/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Investigations Alkaline phosphatase increased	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Investigations Neutrophil count decreased	54.5% 6/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	50.0% 2/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Investigations Platelet count decreased	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Investigations White blood cell decreased	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	25.0% 1/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Nervous system disorders Syncope	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Vascular disorders Hypertension	9.1% 1/11 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.	0.00% 0/4 • Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60