Trial · NCT03258554
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
NCT03258554, Phase 2, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2023-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin. Trials, record NCT03258554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03258554
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
- NCT number
- NCT03258554
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma of Unknown Primary, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Interventions
- Cetuximab, Durvalumab, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2017-08-23
- Last updated
- 2026-08-27
- Results first posted
- 2023-10-25
- Limitations and caveats
Phase II (phII) component stopped enrollment early due to toxicity and futility concerns, with 186 of the 234 planned participants, but continued to collect data required for the final phII analysis. Per the protocol, the study did not continue to phase III (phIII). Therefore, the phIII primary outcome measure (OM) of overall survival was analyzed as a phII secondary OM. Accordingly, the phIII PD-L1 and p16 analyses were analyzed using the phII primary OM of progression-free survival.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] | From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT. | DLTs were collected to verify the safety of durvalumab with RT in this population. Safety was determined if ≤ 2 of 8 participants in the cohort had any DLT, in which case the study would proceed to phase II with that dose schedule (DS). The probability for the DS to be deemed too toxic, given a true toxicity rate ≥ 45%, is at least 78%. With a true toxicity rate ≤ 20%, the probability for the DS do be deemed safe is 80%. The full DLT definition does not fit here, but includes all grade 5 AEs, grade 3 or 4 AEs definitely or probably related to durvalumab (DPRD) except for specified AEs and situations, and incomplete or \> 2-week delay completing RT due to immune toxicity DPRD. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, which grade severity from 1=mild to 5=death. Two alternate DSs with a delayed 2nd dose (to reduce/avoid doses concurrent with RT) would be tried if the initial DS was too toxic. |
| Primary | Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported. |
| Primary | Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Overall survival (OS) time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. |
| Secondary | Locoregional Failure (Percentage of Participants With Locoregional Failure) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Locoregional progression is defined as local or regional progression or recurrence, death due to study cancer or unknown causes without documented progression. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure, distant metastasis (competing risk), deaths from other causes (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. |
| Secondary | Distant Metastasis (Percentage of Participants With Distant Metastasis) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Failure is defined as the occurrence of distant metastasis. Failure time is defined as time from randomization to first occurrence of distant metastasis, local or regional progression or recurrence (competing risk), death (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. |
| Secondary | Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. |
| Secondary | Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 | Baseline and 4 months after end of RT (approximately 6.5 months) | Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) scans at baseline and four months after the end of radiation therapy are compared. 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 by Highest Grade Adverse Event Reported | From randomization to last follow-up: weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr. | Common Terminology Criteria for Adverse Events (version 5.0) 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. |
| Secondary | Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year | Baseline and one year after end of radiation therapy (approximately 7 weeks) | The EORTC QLQ C30 Physical Functioning score measures patient reported limitations in physical activities. Possible scores for each score range from 0 to 100, with higher scores indicating better physical functioning. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate. |
| Secondary | Change in MD Anderson Dysphagia Inventory (MDADI) Composite Score at One Year | Baseline and one year after end of radiation therapy (approximately 7 weeks) | The MDADI Composite score measures overall swallowing related quality of life derived from the emotional, functional, and physical scores, excluding the global item. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] | From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT. | The first eight DLT evaluable participants in a given dose schedule cohort. An evaluable participant is defined as a participant who either (1) experienced a DLT and received at least one dose of durvalumab, or (2) received at least one dose of durvalumab and one fraction of radiation therapy (RT) and completed the DLT observation period (4 weeks after RT). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Randomized participants | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Locoregional Failure (Percentage of Participants With Locoregional Failure) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Distant Metastasis (Percentage of Participants With Distant Metastasis) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer) | From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 | Baseline and 4 months after end of RT (approximately 6.5 months) | Randomized participants with 4-month response assessed by PET | percentage of participants | NUMBER |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | From randomization to last follow-up: weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr. | Randomized and started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life (QOL) Analysis | Baseline up to 12 months | |||
| SECONDARY | Change in Swallowing QOL Using Total Composite M. D. Anderson Dysphagia Inventory (MDADI) Score | Baseline up to 1 year |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] | (Lead-in) RT + Durvalumab | 0 | Participants | ||
| Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] | RT + Cetuximab | 63.7 | 95% Confidence Interval 51.3 to 76.1 | percentage of participants | |
| Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] | RT + Durvalumab | 50.6 | 95% Confidence Interval 41.5 to 59.8 | percentage of participants | |
| Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] | RT+ Cetuximab | 77.5 | 95% Confidence Interval 66.7 to 88.3 | percentage of participants | |
| Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] | RT + Durvalumab | 69.3 | 95% Confidence Interval 60.8 to 77.8 | percentage of participants | |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | RT+ Cetuximab | 18.9 | 95% Confidence Interval 10.0 to 29.9 | percentage of participants | |
| Locoregional Failure (Percentage of Participants With Locoregional Failure) | RT + Durvalumab | 31.3 | 95% Confidence Interval 23.0 to 40.0 | percentage of participants | |
| Distant Metastasis (Percentage of Participants With Distant Metastasis) | RT+ Cetuximab | 12.1 | 95% Confidence Interval 5.3 to 22.0 | percentage of participants | |
| Distant Metastasis (Percentage of Participants With Distant Metastasis) | RT + Durvalumab | 9.5 | 95% Confidence Interval 5.0 to 15.7 | percentage of participants | |
| Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer) | RT+ Cetuximab | 5.3 | 95% Confidence Interval 1.4 to 13.4 | percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-in Component | STARTED | (Lead-in) RT + Durvalumab | 10 | |
| Lead-in Component | STARTED | RT + Cetuximab | 0 | |
| Lead-in Component | STARTED | RT + Durvalumab | 0 | |
| Lead-in Component | Started Treatment | (Lead-in) RT + Durvalumab | 10 | |
| Lead-in Component | Started Treatment | RT + Cetuximab | 0 | |
| Lead-in Component | Started Treatment | RT + Durvalumab | 0 | |
| Lead-in Component | COMPLETED | (Lead-in) RT + Durvalumab | 10 | |
| Lead-in Component | COMPLETED | RT + Cetuximab | 0 | |
| Lead-in Component | COMPLETED | RT + Durvalumab | 0 | |
| Lead-in Component | NOT COMPLETED | (Lead-in) RT + Durvalumab | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,491
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 | (Lead-in) RT + Durvalumab | 1 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | RT + Cetuximab | 0 | 61 | |
| other | Anemia | Blood and lymphatic system disorders | RT + Durvalumab | 0 | 119 | |
| other | Anemia | Blood and lymphatic system disorders | (Lead-in) RT + Durvalumab | 0 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | RT + Cetuximab | 19 | 61 | |
| other | Anemia | Blood and lymphatic system disorders | RT + Durvalumab | 43 | 119 | |
| other | Lymph node pain | Blood and lymphatic system disorders | (Lead-in) RT + Durvalumab | 0 | 10 | |
| other | Lymph node pain | Blood and lymphatic system disorders | RT + Cetuximab | 1 | 61 | |
| other | Lymph node pain | Blood and lymphatic system disorders | RT + Durvalumab | 2 | 119 | |
| other | Atrial fibrillation | Cardiac disorders | (Lead-in) RT + Durvalumab | 0 | 10 |
1 to 10 of 1,491Source ClinicalTrials.gov
See all 1,491 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (Lead-in) RT + Durvalumab | 3 | 10 |
| Total, all-cause mortality | RT + Cetuximab | 17 | 63 |
| Total, all-cause mortality | RT + Durvalumab | 41 | 123 |
| Total, other adverse events | (Lead-in) RT + Durvalumab | 10 | 10 |
| Total, other adverse events | RT + Cetuximab | 61 | 61 |
| Total, other adverse events | RT + Durvalumab | 118 | 119 |
| Total, serious adverse events | (Lead-in) RT + Durvalumab | 4 | 10 |
| Total, serious adverse events | RT + Cetuximab | 51 | 61 |
| Total, serious adverse events | RT + Durvalumab | 84 | 119 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39551064 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT03258554/registered?page=2