drugset
drugset / Trial / NCT03498521

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

NCT03498521 ↗

Phase 2 Completed 529 enrolled Hoffmann-La Roche Foundation Medicine · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

Timeline

Start
2018-07-10
Primary completion
2023-02-14
Completion
2024-11-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Alectinib Small molecule 600 mg Oral
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Comparator Carboplatin Small molecule — Intravenous
Comparator Cisplatin Other / unclassified 60 mg/m2 Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Cobimetinib Small molecule 60 mg Oral
Subject Entrectinib Small molecule 600 mg Oral
Subject Erlotinib Small molecule 150 mg Oral
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Ipatasertib Small molecule 400 mg Oral
Subject Ivosidenib Small molecule 500 mg Oral
Subject Olaparib Small molecule 400 mg Oral
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Pemigatinib Small molecule 13.5 mg Oral
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Trastuzumab Monoclonal antibody 600 mg Subcutaneous
Subject Vemurafenib Small molecule 960 mg Oral
Subject Vismodegib Small molecule 150 mg Oral

Indications

cancer of unknown primary site