Nivolumab/Ipilimumab in Second Line CUP-syndrome

NCT04131621 | Unknown Phase 2 DMC

• 1 other identifier: CA209-8WY
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cancer of Unknown Primary Site

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Months

  3 months

Study Arms (1)

Nivolumab/Ipilimumab

EXPERIMENTAL

Biological: Nivolumab/Ipilimumab

Interventions

Nivolumab/Ipilimumab BIOLOGICAL

Immune checkpoint inhibitor combination

Nivolumab/Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Availability of test reports confirming local CUP diagnosis. If test reports confirming local CUP diagnosis are not available, an FFPE block must be submitted that is sufficient to allow for central confirmation of CUP diagnosis
• Disease relapse or progression after at least three cycles of a platinum-based standard chemotherapy. There is no upper limit of prior treatments received.
• ECOG performance status of 0 - 2
• Life expectancy ≥ 12 weeks
• Eligible for immune checkpoint inhibitor

You may not qualify if:

• 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
• Subjects with a single, small tumor potentially resectable and/or amenable to radiotherapy with curative intent
• Colon cancer-type CUP
• Known presence of brain or spinal cord metastasis (including metastases that have been irradiated), as determined by CT or magnetic resonance imaging (MRI) evaluation during screening
• History or known presence of leptomeningeal disease
• Uncontrolled or symptomatic hypercalcemia (serum calcium ≥ 2.9mmol/L)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University of Heidelberg

Heidelberg, Germany

RECRUITING

Related Publications (1)

• Pouyiourou M, Kraft BN, Wohlfromm T, Stahl M, Kubuschok B, Loffler H, Hacker UT, Hubner G, Weiss L, Bitzer M, Ernst T, Schutt P, Hielscher T, Delorme S, Kirchner M, Kazdal D, Ball M, Kluck K, Stenzinger A, Bochtler T, Kramer A. Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial. Nat Commun. 2023 Oct 24;14(1):6761. doi: 10.1038/s41467-023-42400-5.

  PMID: 37875494 DERIVED

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Alwin Kraemer

CONTACT

0049622142; a.kraemer@dkfz.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: December 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

DE (1)