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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 (CUPISCO)

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ClinicalTrials.gov Identifier: NCT03498521
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Foundation Medicine, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Cancer of Unknown Primary Site Drug: Alectinib Drug: Vismodegib Drug: Ipatasertib Drug: Olaparib Drug: Erlotinib Drug: Bevacizumab Drug: Vemurafenib Drug: Cobimetinib Drug: Trastuzumab Subcutaneous (SC) Drug: Pertuzumab Drug: Atezolizumab Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : April 16, 2022
Estimated Study Completion Date : April 16, 2022

Arm Intervention/treatment
Experimental: Molecularly-Guided Therapy
Participants will be assigned molecularly-guided therapy based on genetic profile.
Drug: Alectinib
Alectinib will be administered orally at the label-recommended dose (600 mg) twice daily until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months).

Drug: Vismodegib
Vismodegib will be administered orally at the label-recommended dose (150 mg) once daily until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months).

Drug: Ipatasertib
Ipatasertib will be administered orally at the label-recommended dose (400 mg) once daily until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months).

Drug: Olaparib
Olaparib will be administered orally at the label-recommended dose (400 mg) twice daily until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months).

Drug: Erlotinib
Erlotinib will be administered orally in combination with Bevacizumab at the label recommended dose (150 mg) once daily until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Bevacizumab
Bevacizumab will be administered intravenously at 15mg/kg every 3 weeks in combination with Erlotinib until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Vemurafenib
Vemurafenib will be administered orally, 960 mg twice daily, in combination with Cobimetinib, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Cobimetinib
Cobimetinib will be administered orally, 60mg once daily, in combination with Vemurafenib, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Trastuzumab Subcutaneous (SC)
Trastuzumab will be administered subcutaneously, 600 mg every 3 weeks, in combination with Pertuzumab and chemotherapy, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Pertuzumab
Pertuzumab will be initially be administered intravenously, 840 mg, followed by 420 mg every 3 weeks, in combination with Trastuzumab and chemotherapy, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Atezolizumab
Atezolizumab will be administered intravenously at the label-recommended dose (1200 mg) every 3 weeks until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months).

Active Comparator: Platinum-Based Chemotherapy
Participants will receive platinum-doublet) chemotherapy (Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, or Carboplatin/Gemcitabine)
Drug: Trastuzumab Subcutaneous (SC)
Trastuzumab will be administered subcutaneously, 600 mg every 3 weeks, in combination with Pertuzumab and chemotherapy, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Pertuzumab
Pertuzumab will be initially be administered intravenously, 840 mg, followed by 420 mg every 3 weeks, in combination with Trastuzumab and chemotherapy, until disease progression or unacceptable toxicity, through the end of the study (approximately 48 months)

Drug: Carboplatin
Carboplatin will be administered intravenously at the area under the curve (AUC) dose once every 3 weeks in combination with Paclitaxel or Gemcitabine, until disease progression or unacceptable toxicity, for up to 6 cycles (Cycle = 21 days).

Drug: Paclitaxel
Paclitaxel will be administered intravenously, 175 mg/m^2, once every 3 weeks in combination with Carboplatin, until disease progression or unacceptable toxicity, for up to 6 cycles (Cycle = 21 days).

Drug: Cisplatin
Cisplatin will be administered intravenously, 60-75 mg/m^2, in combination with Gemcitabine or Paclitaxel, once every three weeks, until disease progression or unacceptable toxicity, for up to 6 cycles (Cycle = 21 days).

Drug: Gemcitabine
Gemcitabine will be administered intravenously, 1000 mg/m^2, twice every three weeks, in combination with Cisplatin or Carboplatin, until disease progression or unacceptable toxicity, for up to 6 cycles (Cycle = 21 days).




Primary Outcome Measures :
  1. Progression Free Survival (PFS1) [ Time Frame: Randomization to the first occurrence of disease progression as assessed by the investigator according to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) or death from any cause, through the end of study (approximately 48 months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization to death from any cause, through the end of study (approximately 48 months) ]
  2. Overall Response Rate (ORR1) [ Time Frame: Two consecutive occurrences of complete or partial response >/=4 weeks apart ]
  3. Duration of Clinical Benefit (DCB1) [ Time Frame: From the first occurrence of a complete response (CR), partial response (PR), or stable disease (SD) after randomization, until disease progression or death from any cause, through the end of study (approximately 48 months) ]
  4. Percentage of Participants with Adverse Events (AE) [ Time Frame: From baseline through the end of study (approximately 48 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed cancer of unknown primary site (CUP)(non-specific subset) according to criteria from the European Society for Medical Oncology, version 1 (ESMO v1)
  • Each patient must provide a blood sample for genomic profiling
  • 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 doublet chemotherapy (according to the reference information for the intended doublet therapy)
  • 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 that is sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory

Exclusion Criteria:

  • Squamous cell CUP
  • 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 24 months after the last dose of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498521


Contacts
Contact: Reference Study ID Number: MX39795 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Foundation Medicine, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03498521     History of Changes
Other Study ID Numbers: MX39795
2017-003040-20 ( EudraCT Number )
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Paclitaxel
Gemcitabine
Atezolizumab
Olaparib
Pertuzumab
Vemurafenib
Albumin-Bound Paclitaxel
Cisplatin
Bevacizumab
Carboplatin
Trastuzumab
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors