NCT02554812 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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

Measure: GEOMETRIC_MEAN
Unit: Nanogram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 1-hour post-dose (at end of infusion) on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6, 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 2, 4, 6, 10

What was measured

Cmax is maximum observed plasma concentration.

Analysis population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 2 Day 1.

Groups in this outcome

Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab

During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab

During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab

During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab

During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab

During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab

During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab

During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab

During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab

During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab

During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

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