A PHASE II, RANDOMIZED, ACTIVE-CONTROLLED, MULTI-CENTER STUDY COMPARING THE EFFICACY AND SAFETY OF TARGETED THERAPY OR CANCER IMMUNOTHERAPY GUIDED BY GENOMIC PROFILING VERSUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH CANCER OF UNKNOWN PRIMARY SITE WHO HAVE RECEIVED THREE CYCLES OF PLATINUM DOUBLET CHEMOTHERAPY

JRCT ID: jRCT2071200082

Registered date:15/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: CANCER OF UNKNOWN PRIMARY
• Date of first enrollment: 08/06/2020
• Target sample size: 790
• Countries of recruitment: Australia,Japan,Austria,Japan,Brazil,Japan,Bulgaria,Japan,Chile,Japan,Colombia,Japan,Croatia,Japan,Cyprus,Japan,Czech Republic,Japan,Denmark,Japan,Estonia,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Kazakhstan,Japan,Korea,Japan,Latvia,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Alectinib:an oral dosage of 300 mg BID
Atezolizumab:1200 mg IV infusion Q3W
Bevacizumab:15 mg/kg IV infusion Q3W
Cobimetinib:60 mg QD for the first 21 days of a 28-day treatment
Entrectinib:an oral dosage of 600 mg QD
Erlotinib:an oral dosage of 150 mg QD
Ipatasertib:orally at the dose of 400 mg QD on Days 1 to 21 of a 28-day cycle
olaparib:an oral dosage of 300 mg BID
Pertuzumab:840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes
Trastuzumab:an intravenous infusion of 8 mg/kg as loading dose, then 6 mg/kg as maintenance dose every 3 weeks
Vemurafenib:an oral dosage of 960 mg BID
Carboplatin:Specified dose, IV
Cisplatin:Specified dose, IV
Gemcitabine:Specified dose, IV
Paclitaxel:Specified dose, IV
Pemigatinib:13.5 mg QD

Outcome(s)

Primary Outcome

Efficacy
term of progression-free survival

Secondary Outcome

Safety,Efficacy
- terms of overall survival, overall response rate and duration of clinical benefit in patients
- Incidence, nature and severity of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically-confirmed unresectable CUP diagnosed according to the criteria defined in the 2015 ESMO Clinical Practice Guidelines for CUP
- At least one lesion that is measurable according to RECIST v1.1
- Availability of a tumor sample that expected to be sufficient and suitable
- No prior systemic therapy for the treatment of CUP
- ECOG performance status of 0 or 1

Exclude criteria

- Squamous cell CUP
- Histology and immunohistology profiles that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma.
- Patients with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
- Patients belonging to any of CUP with favorable prognoses
- Known presence of brain or spinal cord metastasis

Related Information

• Primary Sponsor: Andreas Beringer
• Secondary ID(s): NCT03498521