Trial · NCT03341936
Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN
NCT03341936, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2022-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN. Trials, record NCT03341936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03341936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN
- NCT number
- NCT03341936
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Nivolumab, Lirilumab
- First posted
- 2017-11-14
- Last updated
- 2025-06-18
- Results first posted
- 2022-06-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-Year Disease-Free Survival Percentage | 1 year since salvage surgery, up to 1 year and 23 days since treatment start | The percentage of patients who were alive and disease free at one year past salvage surgery. Patients who were alive at last contact prior to the one year mark are censored. Data analysis conducted through Kaplan Meier methods. |
| Secondary | Response at Time of Salvage Surgery | At the time of salvage surgery, up to 23 days from treatment start date. | Response is classified using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Complete Response - Disappearance of all lesions and pathologic lymph nodes. Partial Response - At least 30% decrease in sum of longest diameters (SLD) for the target lesions, no new lesions, and no progression of non-target lesions. Progressive Disease - At least 20% increase in SLD compared to smallest SLD in study or progression of non-target lesions or development of new lesions Stable Disease - No Partial Response and no Progressive Disease. |
| Secondary | Median Disease-Free Survival Rate | Up to 27.2 months post salvage surgery, up to 28 months total. | The median time that patients were alive and disease free after salvage surgery. Patients who were alive at last contact are censored at last contact. Data analysis conducted through Kaplan Meier methods |
| Secondary | 1-Year Overall Survival Percentage | 1 year post salvage surgery, up to 1 year and 23 days post treatment start. | Percentage of participants who were alive at 1 year since salvage surgery. Patients alive at last contact prior to 1 year were censored. |
| Secondary | Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score | Measured at baseline and then at time of salvage surgery, up to 23 days. | The median change in Programmed Cell Death Ligand - 1 Combined Positive Score (PD-L1 CPS) from baseline to surgery. The score is derived from tumor tissue samples that measures the presence of both tumor and immune cell staining for the PD-L1 marker. Scored from 0-100, a higher score suggests the patient might respond better to treatment. A pathological responder is defined as having less than 50% viable tumor at the time of surgery. |
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 | 1-Year Disease-Free Survival Percentage | 1 year since salvage surgery, up to 1 year and 23 days since treatment start | percentage of participants | NUMBER | |
| SECONDARY | Response at Time of Salvage Surgery | At the time of salvage surgery, up to 23 days from treatment start date. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Disease-Free Survival Rate | Up to 27.2 months post salvage surgery, up to 28 months total. | months | MEDIAN | |
| SECONDARY | 1-Year Overall Survival Percentage | 1 year post salvage surgery, up to 1 year and 23 days post treatment start. | percentage of participants | NUMBER | |
| SECONDARY | Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score | Measured at baseline and then at time of salvage surgery, up to 23 days. | Outcomes were compared among responders and non-responders. | score | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 1-Year Disease-Free Survival Percentage | Nivolumab+Lirilumab | 55.2 | 95% Confidence Interval 34.8 to 71.7 | percentage of participants | |
| Response at Time of Salvage Surgery | Nivolumab+Lirilumab | Stable Disease | 27 | Participants | |
| Response at Time of Salvage Surgery | Nivolumab+Lirilumab | Progressive Disease | 1 | Participants | |
| Median Disease-Free Survival Rate | Nivolumab+Lirilumab | 12.9 | 95% Confidence Interval 8.18 to NA | months | |
| 1-Year Overall Survival Percentage | Nivolumab+Lirilumab | 85.7 | 95% Confidence Interval 66.3 to 94.4 | percentage of participants | |
| Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score | Nivolumab+Lirilumab | Responder | 2.5 | Full Range -45 to 75 | score |
| Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score | Nivolumab+Lirilumab | Non-Responder | 0 | Full Range -45 to 49 | score |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab+Lirilumab | 29 | |
| Overall Study | Treated | Nivolumab+Lirilumab | 28 | |
| Overall Study | COMPLETED | Nivolumab+Lirilumab | 18 | |
| Overall Study | NOT COMPLETED | Nivolumab+Lirilumab | 11 |
Source ClinicalTrials.gov
Adverse events148
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 | Nivolumab+Lirilumab | 7 | 28 | |
| other | Sinus bradycardia | Cardiac disorders | Nivolumab+Lirilumab | 2 | 28 | |
| other | Ear pain | Ear and labyrinth disorders | Nivolumab+Lirilumab | 8 | 28 | |
| other | Hearing impaired | Ear and labyrinth disorders | Nivolumab+Lirilumab | 4 | 28 | |
| other | Tinnitus | Ear and labyrinth disorders | Nivolumab+Lirilumab | 2 | 28 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab+Lirilumab | 18 | 28 | |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Nivolumab+Lirilumab | 1 | 28 | |
| other | Conjunctivitis | Eye disorders | Nivolumab+Lirilumab | 1 | 28 | |
| other | Retinal detachment | Eye disorders | Nivolumab+Lirilumab | 1 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | Nivolumab+Lirilumab | 3 | 28 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab+Lirilumab | 7 | 28 |
| Total, other adverse events | Nivolumab+Lirilumab | 28 | 28 |
| Total, serious adverse events | Nivolumab+Lirilumab | 12 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03341936
GET https://conductscience.org/api/trials/v1/NCT03341936/events?page=2