Overview

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

Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Foundation Medicine, Inc.
Treatments:
Albumin-Bound Paclitaxel
Atezolizumab
Bevacizumab
Carboplatin
Cisplatin
Entrectinib
Erlotinib Hydrochloride
Gemcitabine
Ivosidenib
Olaparib
Paclitaxel
Pertuzumab
Trastuzumab
Vemurafenib
Criteria
Inclusion Criteria:

- Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed
according to criteria defined in the 2015 European Society for Medical Oncology (ESMO)
Clinical Practice Guidelines for CUP

- No prior lines of systemic therapy for the treatment of CUP

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Candidate for platinum-based chemotherapy (according to the reference information for
the intended chemotherapy)

- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors, version 1.1 (RECIST v1.1)

- Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample expected to be sufficient for generation of a comprehensive genomic profile at a
central reference pathology laboratory

Exclusion Criteria:

- Squamous cell CUP

- Participants who can be assigned to a specific subset of CUP for which a specific
treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with
a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis
CUP subsets): Poorly differentiated carcinoma with midline distribution; women with
papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving
only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes;
poorly differentiated neuroendocrine tumors; men with blastic bone metastases and
elevated prostate-specific antigen (PSA); participants with a single, small,
potentially resectable tumor; colon cancer-type CUP, including participants with a CK7
negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive,
CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma
or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC
profile indicative of breast cancer and either a history of breast cancer or lymph
nodes in the drainage areas of the breast; high-grade serious carcinoma histology and
elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass
or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma
and renal lesions, with a Bosniak classification higher than IIF; IHC profile
compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal
carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only
pulmonary metastases and/or lymph nodes in the drainage areas of the liver

- Known presence of brain or spinal cord metastasis (including metastases that have been
irradiated only)

- Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not
adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma

- History or known presence of leptomeningeal disease

- Known human immunodeficiency virus (HIV) infection

- Significant cardiovascular disease

- Prior allogeneic stem cell or solid organ transplantation

- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or for up to 7 months after the final dose of treatment