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Nivolumab/Ipilimumab in Second Line CUP-syndrome | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Nivolumab/Ipilimumab in Second Line CUP-syndrome

A Phase II, Open-label, Non-randomized, Multi-center Study Evaluating the Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Cancer of Unknown Primary Site Who Are Relapsed After or Refractory to Platinum-based Chemotherapy

NCT04131621•University Hospital Heidelberg

View on ClinicalTrials.gov

Summary

To compare the efficacy of nivolumab plus ipilimumab in subjects with high vs. Intermediate/low TMB poor-prognosis CUP (non-specific subset) who are relapsed or refractory to platinum-based first-line chemotherapy. To evaluate the efficacy of nivolumab plus ipilimumab in subjects with poor-prognosis CUP (non-specific subset) who are relapsed or refractory to platinum-based first-line chemotherapy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent Form
•Able and willing to comply with the study protocol
•Age ≥ 18 years at time of signing Informed Consent Form
•Histologically-confirmed disseminated or advanced unresectable CUP diagnosed according the criteria defined in the 2015 ESMO Clinical Practice Guidelines for CUP. Acceptable disease histology includes:
•* Adenocarcinoma of unknown primary site (ACUP)
•* Poorly differentiated adenocarcinoma of unknown primary site
•* Poorly differentiated carcinoma of unknown primary site
•* Squamous cell carcinoma of unknown primary site (SCUP)
•At least one lesion that is measurable according to RECIST v1.1
•Availability of a tumor FFPE block either fresh or archival if obtained ≤ 6 months at Screening that is sufficient for generation of a TruSight Oncology 500 (TSO500) panel at the central reference pathology laboratory
+9 more criteria

Exclusion Criteria

•Subjects with any of the specific non-CUP neoplasms identified in the ESMO CUP guidelines, including:
•* Non-epithelial cancer
•* Extragonadal germ-cell tumor
•Subjects belonging to any of the following subsets of CUP with favorable prognoses:
•* 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 restricted to cervical lymph nodes
•* Poorly and well differentiated neuroendocrine tumors
•* Men with blastic bone metastases and elevated PSA
+24 more criteria

Locations (1)

University of Heidelberg

Heidelberg, Germany

Key Dates

Start Date

December 12, 2019

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

April 15, 2020

Enrollment

194

ESTIMATED participants

Conditions

Cancer of Unknown Primary Site

Interventions

Nivolumab/Ipilimumab

BIOLOGICAL

Contacts

Alwin Kraemer

CONTACT

0049622142 a.kraemer@dkfz.de

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COMPLETEDPHASE2

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

Cancer of Unknown Primary Site

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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