Trial · NCT02578641
A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
NCT02578641, Phase 3, Completed, Tessa Therapeutics; results first posted 2023-06-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients. Trials, record NCT02578641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02578641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
- NCT number
- NCT02578641
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Tessa Therapeutics
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- autologous EBV specific Cytotoxic T cells, combination IV gemcitabine and IV carboplatin (AUC2)
- First posted
- 2015-10-19
- Last updated
- 2023-06-28
- Results first posted
- 2023-06-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until death, assessed up to 7 years. Survivors and lost to follow-up subjects were censored at the date of last contact. Survival follow-up was done every 12 weeks from end of treatment. | Efficacy of EBV-CTL following first line chemotherapy was compared to chemotherapy alone in terms of OS of subjects with advanced nasopharyngeal carcinoma. Overall survival was defined as the duration in months from the day of randomization until death from any cause for a subject known to be deceased, or censored at the last contact date that a subject was known to be alive or lost to follow-up. |
| Secondary | Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until first occurrence of disease progression or death of any cause, whichever occurred first, assessed up to 7 years. Subjects who received subsequent anti-cancer therapy were censored at the date of last tumor assessment. | Progression-free survival was defined as the duration from randomization to the first occurrence of documented disease progression \[based on imaging results\] or death from any cause, whichever occurred first. |
| Secondary | Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Overall response rate was assessed by sites using computed tomography/magnetic resonance imaging based on RECIST version 1.1, which defined Complete Response (CR) as disappearance of all lesions and pathologic lymph nodes; Partial Response (PR) as \>=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; Stable disease (SD) as no PR and no progressive disease (PD); PD as \>=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. The ORR for each treatment arm was comprised of the proportion of subjects who achieved a best overall response of CR or PR while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline. Subjects who achieved CR or PR are responders, otherwise are non-responders. |
| Secondary | Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Clinical benefit rate (CBR) was assessed using computed tomography/magnetic resonance imaging based on RECIST version 1.1., which defined CR as disappearance of all lesions and pathologic lymph nodes; PR as \>=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; SD as no PR and no PD; PD as \>=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. CBR was defined as the proportion of subjects who achieved CR, PR, or SD while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline. |
| Secondary | Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Best overall response (BOR) was assessed using computed tomography/magnetic resonance imaging based on RECIST version 1.1., which defined CR as disappearance of all lesions and pathologic lymph nodes; PR as \>=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; SD as no PR and no PD; PD as \>=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. The BOR of each treatment arm consisted of CR, PR, SD, PD, NE, and NA while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline. The ORR was comprised of the proportion of subjects who achieved a BOR of CR or PR. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until death, assessed up to 7 years. Survivors and lost to follow-up subjects were censored at the date of last contact. Survival follow-up was done every 12 weeks from end of treatment. | Intent-to-Treat Analysis Set | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until first occurrence of disease progression or death of any cause, whichever occurred first, assessed up to 7 years. Subjects who received subsequent anti-cancer therapy were censored at the date of last tumor assessment. | Intent-to-Treat Analysis Set | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Intent-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Intent-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. | From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm. | Intent-to-Treat Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo + EBV-CTL | 25 | 95% Confidence Interval 19.7 to 31.8 | Months | |
| Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo Only | 24.9 | 95% Confidence Interval 19.7 to 32.8 | Months | |
| Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo + EBV-CTL | 7.9 | 95% Confidence Interval 7.1 to 8.2 | Months | |
| Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo Only | 8.5 | 95% Confidence Interval 8.1 to 9.6 | Months | |
| Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo + EBV-CTL | Responders (CR/PR) | 100 | Participants | |
| Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo Only | Responders (CR/PR) | 105 | Participants | |
| Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo + EBV-CTL | Non-Responders (SD/PD/NA/NE) | 64 | Participants | |
| Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo Only | Non-Responders (SD/PD/NA/NE) | 61 | Participants | |
| Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo + EBV-CTL | Clinical Benefit (CR/PR/2 consecutive SD) | 139 | Participants | |
| Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. | Chemo Only | Clinical Benefit (CR/PR/2 consecutive SD) | 136 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemo + EBV-CTL | 164 | |
| Overall Study | STARTED | Chemo Only | 166 | |
| Overall Study | Treatment Received: Gemcitabine/ Carboplatin | Chemo + EBV-CTL | 163 | |
| Overall Study | Treatment Received: Gemcitabine/ Carboplatin | Chemo Only | 162 | |
| Overall Study | Treatment Received: EBV-CTL | Chemo + EBV-CTL | 133 | |
| Overall Study | Treatment Received: EBV-CTL | Chemo Only | 0 | |
| Overall Study | COMPLETED | Chemo + EBV-CTL | 55 | |
| Overall Study | COMPLETED | Chemo Only | 99 | |
| Overall Study | NOT COMPLETED | Chemo + EBV-CTL | 109 | |
| Overall Study | NOT COMPLETED | Chemo Only | 67 |
Source ClinicalTrials.gov
Adverse events262
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 | Chemo + EBV-CTL | 111 | 163 | |
| other | Anemia | Blood and lymphatic system disorders | Chemo Only | 101 | 162 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemo + EBV-CTL | 63 | 163 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemo Only | 65 | 162 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemo + EBV-CTL | 47 | 163 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemo Only | 52 | 162 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemo + EBV-CTL | 39 | 163 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemo Only | 49 | 162 | |
| other | Platelet count decreased | Investigations | Chemo + EBV-CTL | 61 | 163 | |
| other | Platelet count decreased | Investigations | Chemo Only | 81 | 162 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemo + EBV-CTL | 16 | 163 |
| Total, all-cause mortality | Chemo Only | 8 | 162 |
| Total, other adverse events | Chemo + EBV-CTL | 163 | 163 |
| Total, other adverse events | Chemo Only | 162 | 162 |
| Total, serious adverse events | Chemo + EBV-CTL | 68 | 163 |
| Total, serious adverse events | Chemo Only | 46 | 162 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39241963 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemo + EBV-CTL vs Chemo Only: deaths from any cause | Trial comparisons |
| Chemo + EBV-CTL vs Chemo Only: 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.
GET https://conductscience.org/api/trials/v1/NCT02578641
GET https://conductscience.org/api/trials/v1/NCT02578641/results?page=2