Indianapolis, INNCT07306559Now EnrollingIRB Ready

Advanced Relapsed or Refractory Germ Cell Tumours Clinical Trial in Indianapolis, IN

Access cutting-edge advanced relapsed or refractory germ cell tumours treatment through this phase 1 clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Boehringer Ingelheim

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Expert Care in Indianapolis

Access advanced relapsed or refractory germ cell tumours specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related advanced relapsed or refractory germ cell tumours treatment provided free

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Check if you qualify for this advanced relapsed or refractory germ cell tumours clinical trial in Indianapolis, IN

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Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Advanced Relapsed or Refractory Germ Cell Tumours Study in Indianapolis

This study is open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not successful. People can join the study if they have no remaining treatment options or if standard therapy is not suitable. The purpose of this study is to test increasing doses of BI 3820768 to find a dose that people with these types of cancer can tolerate and that may make tumours shrink. BI 3820768 is a type of treatment that may help the immune system fight cancer. This is the first time BI 3820768 is being tested in humans. The study has 2 parts based on the way BI 3820768 is given. Depending on when participants join the study, they will receive BI 3820768 through one of two ways to inject the study medicine. All participants receive the study medicine. The medicine is given as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3 weeks. Participants are in the study for up to 3 years if they are benefiting from the treatment. During this time, they visit the study site regularly, and some visits will require overnight stays. Doctors will regularly check the size of the tumour and whether it has spread. Researchers want to find the highest dose of BI 3820768 that participants can tolerate by looking at the number of participants with certain severe health problems. The doctors also regularly check participants' health, take blood samples, and note any unwanted effects.

Sponsor: Boehringer Ingelheim

Who Can Participate

Inclusion Criteria

Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the informed consent forms (ICFs).
For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.
Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.
Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.
Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Further inclusion criteria apply.

Exclusion Criteria

Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and/or Sponsor's assessment).
Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:
Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Other effectively treated malignancy that is considered cured by local treatment
Patient with known leptomeningeal disease or spinal cord compression due to disease.
Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 h prior to the first dose of trial medication are not eligible.
Patients with Hepatitis-C-Virus (HCV) infection, defined as:
Currently receiving curative antiviral treatment for HCV infection, and/or
HCV viral load is above the limit of quantification (HCV RNA positive).
Patients with active hepatitis B virus (HBV) infection (chronic or acute); defined as having a positive hepatitis B surface antigen (HBsAg), and HBsAg test at screening.
Patient with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBcAb) and absence of HbsAg) are eligible. HBV DNA must be obtained in these patients prior study start. Further exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT07306559) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Relapsed or Refractory Germ Cell Tumours Treatment Options in Indianapolis, IN

If you're searching for advanced relapsed or refractory germ cell tumours treatment options in Indianapolis, IN, this clinical trial (NCT07306559) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced advanced relapsed or refractory germ cell tumours specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced relapsed or refractory germ cell tumours clinical trials near you to find additional studies recruiting in your area.

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