A Phase 3 interventional study of Cetuximab and Cisplatin/Carboplatin in Carcinoma, Squamous Cell of Head and Neck, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 3, Interventional, and Treatment
This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 243 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Cetuximab · Drug: Cisplatin/Carboplatin · Drug: 5-fluorouracil
Drug: Cisplatin/Carboplatin · Drug: 5-fluorouracil
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.
Also known as: Erbitux
Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.
Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.
Also known as: 5-FU
Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Time frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Progression-free Survival (PFS) Time, as Assessed by the Investigator
PFS time was defined as the time in months from the date of randomization until first observation of PD (radiologically confirmed by Investigator), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Time frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Overall Survival (OS) Time
The OS time was defined as the time from randomization to the date of death. If a participant was alive at the time of analysis, survival time was censored at the last date when the participant was known to be alive. If this date was after data cut-off, participants were censored at the date of data cut-off. OS was measured using Kaplan-Meier (KM) estimates.
Time frame: Time from date of randomization up to data cutoff (assessed up to 904 days)
Best Overall Response Rate (ORR)
The Best ORR was based on imaging and classified according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. The BOR rate was defined as the number of participants whose BOR was either complete response (CR) or partial response (PR), relative to the number of participants belonging to the trial set of interest. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Disease Control Rate (DCR)
The DCR was based on imaging and classified according to RECIST Version 1.1 criteria. The DCR was defined as the number of participants whose Best Overall Response is either CR, PR or stable disease (SD), divided by the number of participants belonging to the trial set of interest multiplied by 100. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial.
Time frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Duration of Response (DOR)
DOR was determined for participants whose BOR was either CR or PR. It was defined as the time from the first assessment of CR or PR until the event defining PFS time. PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation
An Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time frame: Time from date of randomization up to data cutoff (assessed up to 904 days)
First participant signed informed consent: 31 Jul 2015, Clinical data cut-off: 19 Jan 2018.
| Milestone | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Started | 164 | 79 |
| Completed | 138 | 72 |
| Not completed | 26 | 7 |
| Withdrew: Ongoing at clinical cut-off date | 25 | 4 |
| Withdrew: Randomized, but not treated | 1 | 3 |
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC) | 5.5 (5.4 to 5.6) | 4.2 (3.0 to 5.3) |
PFS time was defined as the time in months from the date of randomization until first observation of PD (radiologically confirmed by Investigator), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Progression-free Survival (PFS) Time, as Assessed by the Investigator | 5.5 (5.5 to 5.7) | 4.6 (2.9 to 5.5) |
The OS time was defined as the time from randomization to the date of death. If a participant was alive at the time of analysis, survival time was censored at the last date when the participant was known to be alive. If this date was after data cut-off, participants were censored at the date of data cut-off. OS was measured using Kaplan-Meier (KM) estimates.
| months | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Overall Survival (OS) Time | 10.2 (9.3 to 11.5) | 8.4 (6.5 to 9.9) |
The Best ORR was based on imaging and classified according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. The BOR rate was defined as the number of participants whose BOR was either complete response (CR) or partial response (PR), relative to the number of participants belonging to the trial set of interest. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Best Overall Response Rate (ORR) | 50 (42.1 to 57.9) | 26.6 (17.3 to 37.7) |
The DCR was based on imaging and classified according to RECIST Version 1.1 criteria. The DCR was defined as the number of participants whose Best Overall Response is either CR, PR or stable disease (SD), divided by the number of participants belonging to the trial set of interest multiplied by 100. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial.
| percentage of participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Disease Control Rate (DCR) | 75.6 (68.3 to 82.0) | 59.5 (47.9 to 70.4) |
DOR was determined for participants whose BOR was either CR or PR. It was defined as the time from the first assessment of CR or PR until the event defining PFS time. PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Weeks | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Duration of Response (DOR) | 18.1 (13.1 to 20.3) | 13.9 (8.7 to 18.1) |
An Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
| Participants | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| TEAEs | 163 | 75 |
| TESAEs | 46 | 21 |
| TEAEs Leading to Death | 11 | 8 |
| AEs Leading to Discontinuation | 27 | 8 |
Collected over Time from date of randomization up to data cutoff (assessed up to 904 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | 105/163 (64.4%) | 46/163 (28.2%) | 163/163 (100%) |
| Cisplatin/Carboplatin + 5-Flurouracil | 54/76 (71.1%) | 21/76 (27.6%) | 73/76 (96.1%) |
| Event | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| Lung infectionInfections and infestations | 6/163 | 4/76 |
| Tumor haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/163 | 3/76 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/163 | 0/76 |
| AnaemiaBlood and lymphatic system disorders | 1/163 | 2/76 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/163 | 2/76 |
| Upper respiratory tract infectionInfections and infestations | 0/163 | 2/76 |
| White blood cell count decreasedInvestigations | 0/163 | 2/76 |
| Obstructive airways disorderRespiratory, thoracic and mediastinal disorders | 0/163 | 2/76 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/163 | 1/76 |
| Atrial fibrillationCardiac disorders | 0/163 | 1/76 |
| Event | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil |
|---|---|---|
| NauseaGastrointestinal disorders | 93/163 | 51/76 |
| Weight decreasedInvestigations | 103/163 | 31/76 |
| VomitingGastrointestinal disorders | 60/163 | 37/76 |
| AnaemiaBlood and lymphatic system disorders | 73/163 | 36/76 |
| RashSkin and subcutaneous tissue disorders | 77/163 | 1/76 |
| ConstipationGastrointestinal disorders | 73/163 | 31/76 |
| Decreased appetiteMetabolism and nutrition disorders | 67/163 | 34/76 |
| White blood cell count decreasedInvestigations | 62/163 | 25/76 |
| NeutropeniaBlood and lymphatic system disorders | 58/163 | 22/76 |
| HypokalaemiaMetabolism and nutrition disorders | 56/163 | 18/76 |
Intention-to-treat (ITT) analysis set included all participants who were randomized to study treatment.
| Age, Continuous(years) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil | Total |
|---|---|---|---|
| Mean | 57.1 ± 9.52 | 57.0 ± 8.99 | 57.1 ± 9.34 |
| Sex: Female, Male(Participants) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil | Total |
|---|---|---|---|
| Female | 18 | 12 | 30 |
| Male | 146 | 67 | 213 |
| Ethnicity (NIH/OMB)(Participants) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 164 | 79 | 243 |
| Race (NIH/OMB)(Participants) | Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | Cisplatin/Carboplatin + 5-Flurouracil | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 164 | 79 | 243 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Merck KGaA, Darmstadt, Germany