Trial · NCT02952586
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
NCT02952586, Phase 3, Terminated, Pfizer; results first posted 2021-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100). Trials, record NCT02952586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02952586
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
- NCT number
- NCT02952586
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 697 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Avelumab, Chemoradiation
- First posted
- 2016-11-02
- Last updated
- 2021-09-22
- Other registries' IDs
- eudract:2016-001456-21
- Results first posted
- 2021-02-24
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months) | PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (\>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event. |
| Secondary | Overall Survival (OS) | From randomization to the date of death or censored date, whichever occurred first (up to 37 months) | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method. |
| Secondary | Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | From randomization until PD or death (up to 37 months) | pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had salvage surgery at the primary site. |
| Secondary | Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months) | Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method. |
| Secondary | Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | From randomization until disease progression or death, whichever occurred first (up to 37 months) | Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than \[\<\] 10 millimeter \[mm\]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (\<10 mm short axis) . PR: Greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized. |
| Secondary | Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator | From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months) | Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method. |
| Secondary | Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator | From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months) | DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:\>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection \>20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | Baseline up to 44 months | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period. |
| Secondary | Number of Participants With Shift From Baseline in Clinical Laboratory Parameters | Baseline up to 15 months | Grade 1 and 3 ranges are: Anemia:Hb:\<LLN-10.0,\<8.0 g/dL;LC decreased (dec):\<LLN-800/mm\^3,500-200/mm\^3;LC increased (inc):grade 3:\>20,000/mm\^3:NC dec:\<LLN-1500/mm\^3;\<1000-500/mm\^3;PC dec:\<LLN-75,000/mm\^3;\<50,000-25,000/mm\^3;WBC dec:\<LLN-3000/mm\^3;\<2000-1000/mm\^3;ALT inc:\>ULN-3.0\*ULN;\>5.0-20.0\*ULN;ALP \& GGT inc:\>ULN-2.5\*ULN;\>5.0-20.0\*ULN;AST inc:\>ULN-3.0\*ULN;\>5.0-20.0\*ULN;BB inc:\>ULN-1.5\*ULN;\>3.0-10.0\*ULN;CH high:\>ULN-300 mg/dL;\>400-500 mg/dL;CPK inc:\>ULN-2.5\*ULN;\>5\*ULN-10\*ULN;Hypercalcemia:\>ULN-11.5;\>12.5-13.5mg/dL;Hyperglycemia:\>ULN-160; \>250-500mg/dL;Hyperkalemia:\>ULN-5.5;\>6.0-7.0mmol/L;Hypermagnesemia:\>ULN-3.0;\>3.0-8.0 mg/dL;Hypernatremia:\>ULN-150; \>155-160 mmol/L;Hypertriglyceridemia;150-300;\>500-1000 mg/dL;Hypoalbuminemia:\<LLN-3;\<2g/dL;Hypocalcemia:\<LLN-8.0;\<8.0-7.0mg/dL;Hypokalemia:\<LLN-3.0;\<3.0-2.5mmol/L;Hypomagnesemia;\<LLN-1.2;\<0.9-0.7 mg/dL;Hyponatremia:\<LLN-130;\<130-120mmol/L; Hypophosphatemia:\<LLN-2.5;\<2.0-1.0mg/dL;lipase \& serum amylase inc:\>ULN-1.5\*ULN;\>2.0-5.0\*ULN. |
| Secondary | Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) | Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months) | FAS included all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death or censored date, whichever occurred first (up to 37 months) | FAS included all randomized participants. | months | MEDIAN |
| SECONDARY | Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | From randomization until PD or death (up to 37 months) | All randomized participants who had salvage surgery at the primary site. | percentage of participants | NUMBER |
| SECONDARY | Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months) | FAS included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | From randomization until disease progression or death, whichever occurred first (up to 37 months) | FAS included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator | From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months) | FAS included all randomized participants. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator | From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months) | Analysis population included all randomized participants who had unconfirmed CR or PR. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | Baseline up to 44 months | Safety analysis set included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Clinical Laboratory Parameters | Baseline up to 15 months | Safety population include all participants who received at least one dose of study drug. Here Overall Number of Participants analyzed signifies number of participants evaluable for this outcome measure and 'Number analyzed' signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure | Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug) | Safety analysis set included all participants who received at least one dose of study drug. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number analyzed signifies participants evaluable for each specified category at each specified time point. | millimeter of mercury | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group455
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) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | Avelumab + Standard of Care Chemotherapy (SOC CRT) | NA | 95% Confidence Interval 16.9 to NA | months | |
| Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator | Placebo + SOC CRT | NA | 95% Confidence Interval 23.0 to NA | months | |
| Overall Survival (OS) | Avelumab + Standard of Care Chemotherapy (SOC CRT) | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Placebo + SOC CRT | NA | 95% Confidence Interval NA to NA | months | |
| Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 0 | 95% Confidence Interval 0.0 to 45.9 | percentage of participants | |
| Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site | Placebo + SOC CRT | 14.3 | 95% Confidence Interval 0.4 to 57.9 | percentage of participants | |
| Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | Avelumab + Standard of Care Chemotherapy (SOC CRT) | NA | 95% Confidence Interval 22.4 to NA | months | |
| Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator | Placebo + SOC CRT | NA | 95% Confidence Interval 25.0 to NA | months | |
| Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 74.0 | 95% Confidence Interval 69.1 to 78.5 | percentage of participants | |
| Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator | Placebo + SOC CRT | 74.9 | 95% Confidence Interval 70.0 to 79.4 | percentage of participants |
1 to 10 of 455Source ClinicalTrials.gov
See all 455 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-In Phase (7 Days) | STARTED | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 350 | |
| Lead-In Phase (7 Days) | STARTED | Placebo + SOC CRT | 347 | |
| Lead-In Phase (7 Days) | Safety Analysis Set | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 348 | |
| Lead-In Phase (7 Days) | Safety Analysis Set | Placebo + SOC CRT | 344 | |
| Lead-In Phase (7 Days) | COMPLETED | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 345 | |
| Lead-In Phase (7 Days) | COMPLETED | Placebo + SOC CRT | 343 | |
| Lead-In Phase (7 Days) | NOT COMPLETED | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 5 | |
| Lead-In Phase (7 Days) | NOT COMPLETED | Placebo + SOC CRT | 4 | |
| CRT for Avelumab or Placebo (63 Days) | STARTED | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 345 | |
| CRT for Avelumab or Placebo (63 Days) | STARTED | Placebo + SOC CRT | 340 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events700
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 | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 206 | 348 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + SOC CRT | 192 | 344 | |
| other | Leukopenia | Blood and lymphatic system disorders | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 64 | 348 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + SOC CRT | 46 | 344 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 33 | 348 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + SOC CRT | 27 | 344 | |
| other | Neutropenia | Blood and lymphatic system disorders | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 102 | 348 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + SOC CRT | 98 | 344 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 45 | 348 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + SOC CRT | 41 | 344 |
1 to 10 of 700Source ClinicalTrials.gov
See all 700 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 86 | 348 |
| Total, all-cause mortality | Placebo + SOC CRT | 62 | 344 |
| Total, other adverse events | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 344 | 348 |
| Total, other adverse events | Placebo + SOC CRT | 340 | 344 |
| Total, serious adverse events | Avelumab + Standard of Care Chemotherapy (SOC CRT) | 184 | 348 |
| Total, serious adverse events | Placebo + SOC CRT | 177 | 344 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33794205 | 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 |
|---|---|
| Avelumab + Standard of Care Chemotherapy (SOC CRT) vs Placebo + SOC CRT: deaths from any cause | Trial comparisons |
| Avelumab + Standard of Care Chemotherapy (SOC CRT) vs Placebo + SOC CRT: 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/NCT02952586
GET https://conductscience.org/api/trials/v1/NCT02952586/registered?page=2