Clinical Trial Results:
Paclitaxel plus cetuximab for the treatment of recurrent and/or metastatic head and neck cancer after first-line checkpoint inhibitor failure: A multicenter, single arm study
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Summary
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EudraCT number |
2019-003114-13 |
Trial protocol |
AT DE |
Global end of trial date |
09 Jan 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jun 2026
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First version publication date |
11 Jun 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PACEACE
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04278092 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
MedUniWien
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Marika Rosner, MedUniWien, +43 14040044450, marika.rosner@meduniwien.ac.at
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Scientific contact |
Thorsten Füreder, MedUniWien, +43 14040044450, thorsten.fuereder@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Jan 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Jan 2025
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jan 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the confirmed Overall Response Rate (CR/PR) rate according to RECIST V 1.1, in patients treated with cetuximab plus paclitaxel for recurrent and/or metastatic SCCHN after pembrolizumab based first-line therapy
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Protection of trial subjects |
CT Thorax/Abdomen every 12 weeks
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Background therapy |
antiemetics and dexamethason before after administration of paclitaxel | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jan 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 43
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Country: Number of subjects enrolled |
Germany: 14
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Worldwide total number of subjects |
57
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EEA total number of subjects |
57
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
32
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From 65 to 84 years |
25
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85 years and over |
0
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Recruitment
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Recruitment details |
Austria: Univ. Hospital Vienna: 20, Univ. Hospital Salzburg: 4, Univ. Hospital Innsbruck: 5, BHS Linz: 10, LKH Wr. Neustadt: 4 Germany: Charite Berlin: 9, Klinikum Stuttgart: 5 | ||||||
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Pre-assignment
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Screening details |
61 patient were screened according to the inclusion and exclusion criteria | ||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Treatment arm | ||||||
Arm description |
There is only one arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Paclitaxel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
175 mg/m2 milligram(s)/square meter
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Investigational medicinal product name |
Cetuximab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
250 mg/m2 milligram(s)/square meter
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Overall trial
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients will receive cetuximab intravenously 400mg/m2 loading dose followed by 250mg/m 2 weekly in combination with paclitaxel 175mg/m 2 three weekly for up to six cycles followed by bi-weekly cetuximab maintenance 500mg/m 2 until tumor progression, unacceptable toxicity or withdrawal of consent
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End points reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
There is only one arm | ||
Subject analysis set title |
Overall trial
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All patients will receive cetuximab intravenously 400mg/m2 loading dose followed by 250mg/m 2 weekly in combination with paclitaxel 175mg/m 2 three weekly for up to six cycles followed by bi-weekly cetuximab maintenance 500mg/m 2 until tumor progression, unacceptable toxicity or withdrawal of consent
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End point title |
Overall Response Rate [1] | |||||||||
End point description |
each QoL scale a mixed model will be specified with the QoL endpoint as outcome, time as fixed (continuous) effect (including necessary higher-order terms) and random intercept and slope. Mean changes from baseline during the study period are calculated from the model estimates with 95% confidence intervals at timepoints of interest. The clinically meaningful difference, indicating a change that would be detectable by patients will be assumed to be a score difference of 10 points or more. Values missing due to progression, which might not be considered to happen at random, will not be imputed since this study wants to draw conclusions regarding QoL of patients under the investigated therapy (and no generalization to patients who leave the study arm after progression is intended). Missing values due to treatment-related AEs will be imputed in sensitivity analyses. All other missing values will be considered as missing at random
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End point type |
Primary
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End point timeframe |
From baseline until end of treatment
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PaceAce was a multicenter, single-arm phase II study evaluating ORR in patients with R/M SCCHN treated with C plus PTX after P-based first-line therapy. A one-sided exact binomial test (α = 0.025) provided 83.6% power to detect a difference between the null hypothesis (ORR π0 ≤ 0.10, based on CheckMate 141 and KEYNOTE-040)27,28 and the alternative (ORR πa ≥ 0.25, per Saleh et al.)29 with a sample size of 50. The study was deemed positive if ≥10 patients achieved CR or PR. Sample size calculation |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
After the first administration of cetuximab/paclitaxel until 30 days following cessation of treatment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI-CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
5.0
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Reporting groups
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Reporting group title |
Treatment-related AEs
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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21 Jan 2021 |
The following inclusion criteria was changed:
- Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a pembrolizumab based regimen given as first line therapy in the platinum sensitive setting (i.e. ≥ 6 months since last platinum exposure) for recurrent and/or metastatic SCCHN
The following exclusion criteria were changed:
- Has had prior pembrolizumab within 1 week prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from (immunerelated) adverse events other than endocrine side effects.
- Has had prior pembrolizumab in the platinum resistant setting (<6 month after last platinum exposure).
S-FU Visit was added
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30 Nov 2021 |
Changes in Inclusion Criteria:
- Female patients of childbearing potential must agree to use highly effective contraception...
- Male patients must agree to use an adequate method of contraception (condom)---
Changes in Exclusion Criteria:
- Any direct relationship to the sponsor, the investigator or the trial site.
- Placement in an institution on the basis of a judicial or administrative order.
Events not considered to be SAEs are hospitalizations which:
Were planned before entry into the clinical study; are for elective treatment of a condition unrelated to the studied indication or its treatment; occur on an emergency outpatient basis and do not result in admission (unless fulfilling other criteria above); are part of the normal treatment or monitoring of the studied indication and are not associated with any deterioration in condition even if they lead to an extension of the planned stay.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
