Trial · NCT04030455
Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer
NCT04030455, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2026-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer. Trials, record NCT04030455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04030455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer
- NCT number
- NCT04030455
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Laryngeal Squamous Cell Carcinoma, Stage II Laryngeal Cancer AJCC v8, Stage III Laryngeal Cancer AJCC v8
- Interventions
- Carboplatin, Cisplatin, Docetaxel, Pembrolizumab
- First posted
- 2019-07-24
- Last updated
- 2026-03-09
- Results first posted
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years) | To determine the clinical benefit rate (CBR) of patients with stage II or III larynx squamous cell carcinoma (SCC) after 2 cycles of pembrolizumab, cisplatin and docetaxel (PCD), and the pathologic complete response (pCR) rate after 4 cycles of PCD. The CBR rate of patients with stage II or III larynx SCC after 2 cycles of PCD is 100%, excluding one patient (measurable data not available). The pCR rate after 4 cycles of PCD is 75.0%. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), diseappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions |
| Secondary | Safety and Tolerability of PCD in Patients With Larynx SCC -- Number of Adverse Events | first administration of investigational agent until 30 days following last dose of study drug; approximately 3 years and 11 months | Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy |
| Secondary | Larynx Preservation Rates for Overall and pCR Patients at 2 Years | study registration to laryngectomy or date of censoring (2 years follow up) | To determine the laryngeal preservation rate (LPR) at 2 years in the overall population and in the subgroup who achieves a pCR. KM method was used. The larynx preservation rate is calculated by dividing the number of patients who did not need a laryngectomy (either total or partial) after initial treatment by the total number of patients who were candidates for such a treatment. |
| Secondary | To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR (RFS) | from first study registration to recurrence after local therapy or death from any cause (up to 2 years follow up) | Relapse free survival is defined as the time from study registration to recurrence after local therapy or death from any cause. Recurrence was counted only if it occurred after definitive local therapy (surgery and/or radiotherapy). Patients achieving durable complete responses to PCD without local therapy, and patients receiving local therapy without subsequent recurrence, were censored at last follow-up. |
| Secondary | To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR. (OS) | first study registration to death due to any cause or date of censuring (up to 2 years follow up) | Overall survival is defined from study registration to death due to any cause or to the date of censoring measure at the last contact. KM method was used. |
| Secondary | DIGEST | baseline, 6 months post treatment, long-term follow up (up to two years) | To determine swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST is a validated psychometric tool used during modified barium swallow studies (MBSSs) to grade swallowing safety, efficiency, and overall pharyngeal swallow function. Scores ranging from 0 to 4, where 0 indicates no impairment, 1=mild, 2=moderate, 3=severe, 4=life threatening. The DIGEST grade was collected at three time points: baseline, 6 months post-treatment and long-term follow-up. One subject without any DIGEST data was excluded from analysis. A linear mixed-effects model was used to evaluate the effects of treatment group (chemo-IO alone vs. radiation/surgery) and time on DIGEST grade across three time points. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of PCD in Patients With Larynx SCC -- Number of Adverse Events | first administration of investigational agent until 30 days following last dose of study drug; approximately 3 years and 11 months | adverse events | NUMBER | |
| SECONDARY | Larynx Preservation Rates for Overall and pCR Patients at 2 Years | study registration to laryngectomy or date of censoring (2 years follow up) | proportion of participants | NUMBER | |
| SECONDARY | To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR (RFS) | from first study registration to recurrence after local therapy or death from any cause (up to 2 years follow up) | proportion of participants | NUMBER | |
| SECONDARY | To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR. (OS) | first study registration to death due to any cause or date of censuring (up to 2 years follow up) | proportion of participants | NUMBER | |
| SECONDARY | DIGEST | baseline, 6 months post treatment, long-term follow up (up to two years) | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Response per RECIST: CR | 12 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Response per RECIST (count): N/A | 1 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Response per RECIST (count): PR | 10 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Response per RECIST (count): SD | 1 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | pCR original category (count): N/A | 1 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | pCR original category (count): No | 4 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | pCR original category (count): Yes | 19 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Survival status at end of study (count): Alive | 20 | Participants | |
| CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) | Experimental (Cis/Doce/Pembro) | Survival status at end of study (count): Dead | 4 | Participants | |
| Safety and Tolerability of PCD in Patients With Larynx SCC -- Number of Adverse Events | Experimental (Cis/Doce/Pembro) | Grade 4 : Definite | 0 | adverse events |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental (Cis/Doce/Pembro) | 28 | |
| Overall Study | COMPLETED | Experimental (Cis/Doce/Pembro) | 24 | |
| Overall Study | NOT COMPLETED | Experimental (Cis/Doce/Pembro) | 4 |
Source ClinicalTrials.gov
Adverse events80
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 | Abdominal pain | Gastrointestinal disorders | Experimental (Cis/Doce/Pembro) | 1 | 24 | |
| other | Alanine aminotransferase increased | Investigations | Experimental (Cis/Doce/Pembro) | 4 | 24 | |
| other | Alkaline phosphatase increased | Investigations | Experimental (Cis/Doce/Pembro) | 5 | 24 | |
| other | Allergic reaction | General disorders | Experimental (Cis/Doce/Pembro) | 3 | 24 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Experimental (Cis/Doce/Pembro) | 10 | 24 | |
| other | Anemia | Blood and lymphatic system disorders | Experimental (Cis/Doce/Pembro) | 18 | 24 | |
| other | Anorexia | Metabolism and nutrition disorders | Experimental (Cis/Doce/Pembro) | 4 | 24 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Experimental (Cis/Doce/Pembro) | 4 | 24 | |
| other | Aspartate aminotransferase increased | Investigations | Experimental (Cis/Doce/Pembro) | 2 | 24 | |
| other | Blood lactate dehydrogenase increased | Investigations | Experimental (Cis/Doce/Pembro) | 5 | 24 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental (Cis/Doce/Pembro) | 4 | 24 |
| Total, other adverse events | Experimental (Cis/Doce/Pembro) | 24 | 24 |
| Total, serious adverse events | Experimental (Cis/Doce/Pembro) | 9 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04030455
GET https://conductscience.org/api/trials/v1/NCT04030455/results?page=2