Phase II study of dornase alpha and cisplatin in germ cell cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodny Onkologicky Ustav

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-07-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To determine the efficacy (as measured by 12-week progression-free survival) of dornase alfa and cisplatin in patients with multiple relapsed/refractory germ cell tumors (GCTs).

Secondary objectives 1

1. To describe the favorable response rate, progression-free survival rate, time to progression and toxic effects of dornase alfa with cisplatin in patients with multiple relapsed/refractory metastatic germ cell cancer.

Conditions and MedDRA coding

germ cell cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. Signed written informed consent
2. Adult men aged 18 years or older.
3. ECOG performance status: 0-1.
4. Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma.
5. Rising serum markers (i.e., alfa-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer.
6. Multiple relapsed/refractory GCTs (at least 2 lines of previous chemotherapy) and/or patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy.
7. Primary mediastinal GCTs in first relapse.
8. Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator.
9. RECIST 1.1 measurable disease.
10. Adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
11. Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST < 3 ULN or < 5 in case of liver metastases. For subjects with Gilbert's syndrome bilirubin > 1.5 × ULN is allowed if no symptoms of compromised liver function are present.
12. Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 50 ml/min. Cockcroft formula: CLcr = [(140-age) x weight (Kg)]/[72 x creat (mg/dl)].
13. At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry.
14. At least 4 weeks must have elapsed since the last major surgery.
15. Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1.
16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
17. Male patients with a female partner of childbearing potential who agree to use an effective method of contraception (condom) and a highly effective method of contraception by their female partner during the study and 6 months after the last study treatment intake.

Exclusion criteria 7

1. Patients who do not fit inclusion criteria.
2. Other prior malignancy except successfully treated nonmelanoma skin cancer.
3. Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy.
4. Female patients.
5. Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study.
6. Hypersensitivity to any compound of the drugs, severe known allergies or intolerance to other recombinant protein products obtained from Chinese hamster ovary cells according to Investigatorś decision.
7. Known participation in another clinical trial investigating a drug and/or medical product in the last 30 days or 5 half-lives of the investigational drug and/or medicinal product (whichever is longer).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 12-week progression-free survival (intent-to-treat population)

Secondary endpoints 6

1. Overall response rate (ORR) by RECIST 1.1 and tumor markers (AFP, HCG, LDH)
2. Progression-free survival
3. Overall survival
4. Toxicity
5. Frequency of grade III and IV adverse events
6. Association between clinical outcome and biomarkers (exploratory analysis)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodny Onkologicky Ustav

Sponsor organisation

Narodny Onkologicky Ustav

Address

Klenova 1, Nove Mesto Nove Mesto

City

Bratislava

Postcode

831 01

Country

Slovakia

Scientific contact point

Organisation

Narodny Onkologicky Ustav

Contact name

Prof. Michal Mego, M.D., DSc

Public contact point

Organisation

Narodny Onkologicky Ustav

Contact name

Prof. Michal Mego, M.D., DSc

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications