NCT01772004 · OUTCOME

Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) · Source last updated 2021-12-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Microgram per milliliter
Interval / dispersion: Standard Deviation
Time frame: At Day 1, 15, 29, 43, 85, 127 and 169

What was measured

Serum concentration at end of infusion (CEOI) of Avelumab is reported.

Analysis population: Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data was reported for those arms for which end of infusion sample were collected as per planned analysis.

Groups in this outcome

Primary Expansion Cohort: NSCLC, First Line

Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Colorectal Cancer

Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Participants with Renal cell carcinoma (Second line) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: Ovarian Cancer

Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: Urothelial Carcinoma

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: GC/GEJC, Third Line

Participants with gastric and gastroesophageal cancer treated with a first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: HNSCC

Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.