Trials Sponsors Conditions Drugs Pricing

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS), defined as thetime from randomization to the first occurrence ofdisease progression, as assessed by theinvestigator according to Response EvaluationCriteria in Solid Tumors, Version 1.1 (RECISTv1.1), or death from any cause, whichever occursfirst.

Secondary Outcomes (8)

Overall survival (OS), defined as the time fromrandomization to death from any cause
Overall response rate (ORR), defined as theproportion of participants who exhibit a CR or PRto study treatment on two consecutive occasions≥ 4 weeks apart.
Duration of clinical benefit (DCB), defined as thetime from the first occurrence of a CR, PR or SDafter treatment start until disease progression ordeath from any cause, whichever occurs first.
Incidence, nature and severity of adverse events(AEs)
Incidence and reasons for any interruptions, orpremature discontinuation of any component ofstudy treatment
+3 more secondary outcomes

Interventions

CISPLATINType not reported

DISODIUM FOLINATEType not reported

Trodelvy 200 mg powder for concentrate for solution for infusionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
CISPLATIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
GEMCITABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INFUSION
View registry record
Formulated product
DOCETAXEL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
OXALIPLATIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
CARBOPLATIN

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

CISPLATIN
Named ingredient: Cisplatin
View registry record
GEMCITABINE
Named ingredient: Gemcitabine
View registry record
DOCETAXEL
Named ingredient: Docetaxel
View registry record
OXALIPLATIN
Named ingredient: Oxaliplatin
View registry record
CARBOPLATIN
Named ingredient: Carboplatin
View registry record
PACLITAXEL
Named ingredient: Paclitaxel
View registry record
FLUOROURACIL
Named ingredient: Fluorouracil
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to understand and give written informed consent
Willing and able to comply with the requirements and restrictions in this protocol
Age ≥ 18 years at time of signing Informed Consent Form

Sponsors & Collaborators

Universitaetsklinikum Heidelberg AöR
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (11)

KEM I Evang. Kliniken Essen-Mitte gGmbH

Essen, 45136, Germany

Almut Brundert+4920117424525 studiensekretariat@kem-med.com

Charite Universitaetsmedizin Berlin KöR

Berlin, 12203, Germany

Damian Rieke+4930450564626 damian.rieke@charite.de

Universitaetsklinikum Heidelberg AöR

Heidelberg, 69120, Germany

Alwin Krämer+4962215638183

Central Study Contacts

Alwin Krämer

+4962215638183 Alwin.Kraemer@med.uni-heidelberg.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

June 1, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-523055-55-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:31:56 UTC

Documents

D1_SACICUP_Protocol_public

You may not qualify if:

Participants with any of the specific non-CUP neoplasms identified in the ESMO CUPguidelines 3
Participants belonging to any of the following subsets of CUP with favorable prognoses: -Single metastatic deposit or oligometastatic disease amenable to local ablativetreatment (single-site or oligometastatic CUP) -Women with isolated axillary lymph node metastases (breast-like CUP) -Women with peritoneal carcinomatosis of a serous papillary adenocarcinoma (ovary-like CUP) -Squamous cell carcinoma involving non-supraclavicular cervical lymph nodes (headand neck-like CUP) -Men with blastic bone metastases and/or IHC or serum PSA expression (prostate-like CUP) -Adenocarcinoma with colorectal IHC (CK7-, CK20+, CDX2+) or molecular profile(colon-like CUP) -Carcinoma with renal cell histological and immunohistochemical profile (renal-likeCUP)
Disease manifestations amenable to resection and/or irradiation with curative intent duringthe course of the study
Known presence of brain or spinal cord metastasis, as determined by CT or magneticresonance imaging (MRI) evaluation during screening. As an exception, patients withbrain metastases are allowed to be included if all of the following five criteria are met: (i)the total number of brain metastases is 5 or less (ii)brain metastases were / are asymptomatic (iii)brain metastases have been completely surgically resected or completelytreated with stereotactic radiosurgery (iv)there was/is no indication for whole-brain irradiation (v)a brain MRI or high-resolution CT-scan at screening shows no evidence ofresidual disease
History or known presence of leptomeningeal disease
Known history of HIV-1 or 2 (or positive HIV-1/2 antibody if done at screening) withdetectable viral load or taking medications that may interfere with SN-38 metabolism
Active hepatitis B (HBV) or active hepatitis C (HCV) (each defined by detectable viral loadsof HBV DNA or HCV RNA, respectively)
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn´s disease) or GIperforation within 6 months of enrollment
Significant cardiovascular disease as defined as any of the following criteria: -myocardial infarction or unstable angina pectoris within 6 months of enrollment -history of serious ventricular arrythmia (ie, ventricular tachycardia or ventricularfibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiringantiarrhythmic medications (except for atrial fibrillation that is well controlled withantiarrhythmic medication); history of QT interval prolongation-NYHA class III or greater congestive heart failure or left ventricular ejection fractionof <40%
History of an active second malignancy other than CUP within 3 years prior to screening.As an exception, patients with malignancies with no evidence of active cancer for threeyears prior to enrollment, or patients with surgically or radiotherapeutically cured tumorswith low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmedcomplete excision of carcinoma in situ, localized prostate cancer, stage I uterine canceror similar) are allowed to enroll
Any other disease, psychiatric condition, metabolic dysfunction, physical examinationfinding, or clinical laboratory finding that contraindicates the use of an investigational drug,may affect the interpretation of the results, or may render the patient at high risk fromtreatment complications
Failure to recover (ie ≥ Grade 2 is considered not recovered) from AEs due to a previouslyadministered agent (patients with any grade neuropathy or alopecia are an exception tothis criterion and qualify for the study)
Positive serum pregnancy test or women who are breastfeeding
Known allergy or hypersensitivity to any component of the study treatment withSacituzumab govitecan, its metabolites or formulation
Previous treatment with topoisomerase 1 inhibitors
+1 more criteria

A phase II, open-label, randomized, multi-center study comparing the efficacy and safety of Sacituzumab govitecan versus investigator's choice in patients with cancer of unknown primary (CUP) who are relapsed after or refractory to platinum-based chemotherapy (SACICUP)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations