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Germ Cell TumorPhase 2ASPIRENCT06866964

A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy

A Phase 2 study testing Low-dose ASA in people with Germ Cell Tumor and Testicular Cancer, run by Wake Forest University Health Sciences at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Germ Cell Tumor, Testicular Cancer
What is being tested?
Low-dose ASA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesUnited States
Study dates
28 Aug 2025to Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent and HIPAA authorization for release of personal health information
  • Age ≥ 18 years and ≤ 70 years at the time of consent
  • Histological confirmation of stage IS or IIA or higher testicular or germ cell cancer. Primary mediastinal and retroperitoneal GCT are allowed. Seminoma and non-seminoma histologies are allowed.
  • Performance Status (PS) of ECOG 0-2 at the time of enrollment
  • At least one of the following "high risk" of VTE features:
  • Stage IIC or III or higher per AJCC 8th edition criteria i. Stage IIC - any pT/TX, N3, M0, S0-1 ii. Stage III - any pT/TX, any N, M1, SX iii. Stage IIIA - any pT/TX, any N, M1a, S0-1 iv. Stage IIIB - any pT/TX, N1-3, M0, S2 or any pT/TX, any N, M1a, S2 v. Stage IIIC - any pT/TX, N1-3, M0, S3 or any pT/TX, any N, M1a, S3 or any pT/TX, any N, M1b, any S Serum marker (S category) S criteria SX Marker studies not available or not performed S0 Marker study levels within normal limits S1 LDH < 1.5 x normal and hCG < 5000 IU/L and AFP <1000 ng/mL S2 LDH 1.5 to 10 x normal or hCG 5000 to 50,000 IU/L or AFP 1000 to 10,000 ng/mL S3 LDH >10 x normal or hCG >50,000 IU/L or AFP >10,000 ng/mL
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  • Intermediate or poor risk by IGCCCG criteria i. Intermediate risk - testis/retroperitoneal primary and no non pulmonary visceral metastases plus at least one of the following markers: AFP > 1,000 ng/mL to ≤ 10,000 ng/mL, beta-hCG > 5,000 IU/L and ≤ 50,000 IU/L, LDH >1.5 x normal and ≤ 10 x normal ii. Poor risk - mediastinal primary or non-pulmonary visceral metastases plus at least one of the following markers: AFP > 10,000 ng/mL, beta- hCG > 50,000 IU/L, LDH > 10 x normal c. Khorana score of 2 or higher i. +1 point for testicular/germ cell cancer (All patients will receive +1 for their testicular/germ cell cancer diagnosis. Thus, a patient with any other Khorana characteristic [ii-v] will meet this inclusion criteria.) ii. +1 point for platelet ≥350 x 10^9/L iii. +1 point for hemoglobin <10 g/dL iv. +1 point for leukocyte count >11 x 10^9/L v. +1 point for BMI >35 kg/m^2
  • Planning or recently started 3-4 cycles of standard of care front-line cisplatin-based chemotherapy (bleomycin, etoposide, and platinum [BEP], etoposide and cisplatin [EP], or etoposide, ifosfamide, and cisplatin [VIP]). Note: ASA should be initiated no later than 2 weeks after initiation of standard front-line chemotherapy.
  • As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
  • Ability to swallow oral medications

Who cannot join

  • Receiving chemotherapy in adjuvant setting
  • Prior VTE/PE
  • Currently taking anticoagulation or antiplatelet therapy. Non-steroidal anti-inflammatory drug (NSAID) use for pain is allowed
  • Prior indication for anticoagulation or anticoagulation contraindicated (e.g., active bleed or risk of bleeding, such as history of gastrointestinal ulcers)
  • Allergy to ASA

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Margarita Dzhanumova contact

980-515-5300

margarita.dzhanumova@advocatehealth.org

United States3 sites, 3 recruiting

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Charlotte, North Carolina, 28204

    Margarita Dzhanumova, 980-515-5300, margarita.dzhanumova@advocatehealth.org

    Landon Brown, MD

    Recruiting

  • Aurora St. Luke's Medical Center MOB

    Milwaukee, Wisconsin, 53215

    Milanka Petrovic, 414-649-5391, milanka.petrovic@aah.org

    Antony Ruggeri, MD

    Recruiting

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

    Michael McCormack, MD, 336-716-7975, Michael.McCormack@advocatehealth.org

    Michael McCormack, MD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls

Read the detailed description

This is a single-arm, two-stage, Phase II study designed to evaluate the 6-month VTE-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose ASA as compared to relevant historical controls. Stage 1 will consist of 13 participants. If at least 9 of those 13 do not experience a VTE event during the first 26 weeks on the ASA, Stage 2 will be activated. Stage 2 will enroll an additional 18 participants for a total of 31. Participants will provide their own supply of ASA. Participants will self-administer a fixed dose of ASA (81 mg) by mouth daily for 26 weeks. Participants who experience the primary endpoint of VTE will stop ASA and start standard of care anticoagulation at the direction of the treating investigator. This study will initially open as a single center study at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) and additional investigational site(s) may be added following activation at the lead site.

Being tested
Low-dose ASA
Keywords
cancer, Venous thromboembolism
Medical subject headings
Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms, Neoplasms, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose ASADrug

    Also called aspirin

    81 mg by mouth daily for 26 weeks

Study groups in NCT06866964
Study groupRoleWhat they receive
Low-dose aspirin (acetylsalicylic acid [ASA])ExperimentalASA has been shown to reduce risk of VTE. It will be self-administered, a fixed dose of ASA (81 mg) by mouth daily for 26 weeks.
Receives: Drug: Low-dose ASA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Venous thromboembolism (VTE)-free

    A binary variable indicating whether the participant had zero VTE events within 26 weeks of initiation of standard chemotherapy. VTE events include objectively confirmed symptomatic or asymptomatic proximal deep-vein thrombosis in a lower limb, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, symptomatic or incidental pulmonary embolism, symptomatic or incidental central catheter related thrombosis, or death from venous thromboembolism.

    Measured: 26 weeks after initiation of standard chemotherapy

Secondary outcomes (4)

  1. Major Bleeding Event

    A categorical variable indicating whether the participant experienced a major bleeding event within 26 weeks of initiation of standard chemotherapy. A major bleeding event is defined by the occurrence of at least one of the following. Bleeding associated with death. Overt bleeding and associated with a decrease from baseline in hemoglobin concentration by at least 2.0 g/L or with the need for transfusion of ≥ 2 units of whole blood or red cells. Bleeding in a critical area or organ such as retroperitoneal, intracranial, intraocular, intraspinal, intraarticular or pericardial, or intramuscular with compartment syndrome as determined by the investigator.

    Measured: 26 weeks after initiation of standard chemotherapy

  2. Clinically Relevant Non-Major Bleeding

    A categorical variable indicating whether the participant experienced clinically relevant non-major bleeding within 26 weeks of initiation of standard chemotherapy. Clinically relevant non-major bleeding is defined as bleeding that leads to a medical intervention, an unscheduled contact with provider, temporary cessation of oral anticoagulants or antiplatelet agent, discomfort for the participant (such as pain) or impairment of activities of daily living.

    Measured: 26 weeks after initiation of standard chemotherapy

  3. Relapse-Free Survival (RFS)

    Calculated from the date of enrollment to the date of first documented evidence of recurrent disease or death, whichever occurred first. For participants who have not relapsed, RFS will be censored at the last disease status assessment. Relapse will be determined by biopsy proven recurrent non-teratoma germ cell tumor, initiation of salvage chemotherapy, or rising tumor markers unequivocally.

    Measured: 2 years after initiation of standard chemotherapy

  4. Overall Survival (OS)

    Calculated from the date of enrollment to the date of death from any cause. Participants who are alive or lost to follow up at the time of the final analysis will be censored at the last known date they were alive.

    Measured: 2 years after initiation of standard chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start28 Aug 2025
  3. Primary completionAug 2029 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866964
Sponsor's protocol ID
IRB00126906
Other IDs
ONC-GU-2402, Pro00085150
Acronym
ASPIRE
Status last verified
Jul 2026
First submitted
4 Mar 2025
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-dose ASA in people with Germ Cell Tumor and Testicular Cancer, run by Wake Forest University Health Sciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Margarita Dzhanumova (980-515-5300, margarita.dzhanumova@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous thromboembolism (VTE)-free (time frame: 26 weeks after initiation of standard chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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