Trial · NCT02605967
Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT02605967, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma. Trials, record NCT02605967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02605967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
- NCT number
- NCT02605967
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Spartalizumab, Investigator choice of chemotherapy
- First posted
- 2015-11-17
- Last updated
- 2022-02-10
- Other registries' IDs
- eudract:2015-000454-38
- Results first posted
- 2021-08-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | From randomization up to maximum 3.3 years | PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record. |
| Primary | Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Median PFS | From randomization up to maximum 3.3 years | PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. |
| Secondary | Overall Survival (OS) | From randomization up to maximum 4.8 years. | Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient is not known to have died, survival is censored at the date of last known date the patient was alive. |
| Secondary | Overall Response Rate (ORR) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on central review of overall lesion response according to RECIST 1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Response (DOR) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR) based on central review of overall lesion response according to RECIST 1.1. DOR is defined as the time between the date of first documented response (confirmed CR or confirmed PR) and the date of first documented disease progression or death due to underlying cancer. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. |
| Secondary | Time to Progression (TTP) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | TTP is defined as time from date of randomization to the date of event defined as the first documented progression or death due to underlying cancer. If a subject did not had an event, TTP was censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was RECIST v1.1. Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. |
| Secondary | Immune-related Progression-free Survival (irPFS) as Per irRC | From randomization up to maximum 3.3 years | irPFS is the time from the date of randomization to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was immune-related Response Criteria (irRC). Immune-related progressive disease is at least a 20% increase in the sum of diameters of all measured target lesions including new measurable lesions. |
| Secondary | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Secondary | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. |
| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. The duration of the dosing interval (tau) was 28 days. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | From randomization up to maximum 3.3 years | All participants to whom study treatment was assigned by randomization. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Median PFS | From randomization up to maximum 3.3 years | All participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to maximum 4.8 years. | All participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | All participants to whom study treatment was assigned by randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | All participants for whom best overall response is complete response (CR) or partial response (PR) as per RECIST 1.1 based on central review. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) as Per RECIST v 1.1 | From randomization up to maximum 3.3 years | All participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Immune-related Progression-free Survival (irPFS) as Per irRC | From randomization up to maximum 3.3 years | All participants to whom study treatment was assigned by randomization to spartalizumab. For the chemotherapy arm, tumor scans for efficacy assessment as per irRC were not planned. | months | MEDIAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization. | hours | MEDIAN |
| SECONDARY | Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of Spartalizumab | pre-dose, 1, 24, 168, 336 and 672 hours post spartalizumab dose on Cycle 1 and Cycle 3. The duration of one cycle was 28 days. | All participants who had at least one dose of spartalizumab and had at least one evaluable concentration measurement of spartalizumab. PK samples were only collected in participants to whom spartalizumab was assigned by randomization. | day*ug/mL | GEOMETRIC_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Spartalizumab 400 mg Q4W | number of progression | 62 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Chemotherapy | number of progression | 32 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Spartalizumab 400 mg Q4W | number of deaths | 3 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Chemotherapy | number of deaths | 1 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Spartalizumab 400 mg Q4W | number of censored | 17 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Number of Participants With Progression or Death | Chemotherapy | number of censored | 7 | Participants | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Median PFS | Spartalizumab 400 mg Q4W | 1.9 | 95% Confidence Interval 1.8 to 2.9 | months | |
| Progression-free Survival (PFS) as Per RECIST v 1.1 Using Central Assessment - Median PFS | Chemotherapy | 5.6 | 95% Confidence Interval 3.7 to 9.2 | months | |
| Overall Survival (OS) | Spartalizumab 400 mg Q4W | 20.1 | 95% Confidence Interval 13.6 to 25.5 | months | |
| Overall Survival (OS) | Chemotherapy | 16.0 | 95% Confidence Interval 8.8 to 22.5 | months |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spartalizumab 400 mg Q4W | 82 | |
| Overall Study | STARTED | Chemotherapy | 40 | |
| Overall Study | Safety Set | Spartalizumab 400 mg Q4W | 82 | |
| Overall Study | Safety Set | Chemotherapy | 39 | |
| Overall Study | Crossover to Spartalizumab | Spartalizumab 400 mg Q4W | 0 | |
| Overall Study | Crossover to Spartalizumab | Chemotherapy | 27 | |
| Overall Study | COMPLETED | Spartalizumab 400 mg Q4W | 0 | |
| Overall Study | COMPLETED | Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Spartalizumab 400 mg Q4W | 82 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 40 |
Source ClinicalTrials.gov
Adverse events576
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 | Anaemia | Blood and lymphatic system disorders | Spartalizumab 400 mg Q4W | 19 | 82 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 19 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossover to Spartalizumab | 6 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | All Spartalizumab Participants | 25 | 109 | |
| other | Leukopenia | Blood and lymphatic system disorders | Spartalizumab 400 mg Q4W | 2 | 82 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 3 | 39 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crossover to Spartalizumab | 0 | 27 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Spartalizumab Participants | 2 | 109 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Spartalizumab 400 mg Q4W | 0 | 82 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Chemotherapy | 2 | 39 |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spartalizumab 400 mg Q4W | 5 | 82 |
| Total, all-cause mortality | Chemotherapy | 3 | 39 |
| Total, all-cause mortality | Crossover to Spartalizumab | 3 | 27 |
| Total, all-cause mortality | All Spartalizumab Participants | 8 | 109 |
| Total, other adverse events | Spartalizumab 400 mg Q4W | 76 | 82 |
| Total, other adverse events | Chemotherapy | 37 | 39 |
| Total, other adverse events | Crossover to Spartalizumab | 25 | 27 |
| Total, other adverse events | All Spartalizumab Participants | 101 | 109 |
| Total, serious adverse events | Spartalizumab 400 mg Q4W | 28 | 82 |
| Total, serious adverse events | Chemotherapy | 15 | 39 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34433653 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Spartalizumab 400 mg Q4W vs Chemotherapy: Overall Response Rate (ORR) as Per RECIST v 1.1 |
Source 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.
GET https://conductscience.org/api/trials/v1/NCT02605967
GET https://conductscience.org/api/trials/v1/NCT02605967/outcomes?page=2