NCT04030455 · OUTCOME
CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD)
Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer · Source last updated 2026-03-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years)
What was measured
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
Groups in this outcome
Experimental (Cis/Doce/Pembro)
cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W IV
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental (Cis/Doce/Pembro) | 24 |
|---|
Reported measurements
Response per RECIST: CR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Response per RECIST (count): N/A
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Response per RECIST (count): PR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Response per RECIST (count): SD
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
pCR original category (count): N/A
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
pCR original category (count): No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
pCR original category (count): Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Survival status at end of study (count): Alive
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Survival status at end of study (count): Dead
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental (Cis/Doce/Pembro) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Response per RECIST: CR
- title
- Response per RECIST (count): N/A
- title
- Response per RECIST (count): PR
- title
- Response per RECIST (count): SD
- title
- pCR original category (count): N/A
- title
- pCR original category (count): No
- title
- pCR original category (count): Yes
- title
- Survival status at end of study (count): Alive
- title
- Survival status at end of study (count): Dead
- description
- 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
- groups
- description
- cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W IV
- id
- OG000
- title
- Experimental (Cis/Doce/Pembro)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years)
- title
- CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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