Study on Immune Therapy with Durvalumab and Tremelimumab for Treating Relapsed or Hard-to-Treat Germ Cell Tumors

Inclusion Criteria

• Must be 18 years or older.
• Weigh more than 30 kg (about 66 pounds).
• Have a confirmed diagnosis of germ cell tumor (GCT), which includes certain types of testicular and ovarian cancers, or tumors in the pineal gland.
• Have measurable disease by scans or elevated tumor markers in the blood.
• Must have had at least one previous treatment for GCT and meet specific criteria for progression or recurrence.
• Patients with brain metastases can join if they have completed treatment for brain metastases, do not need steroids, and have no symptoms.
• Must be in good general health with an ECOG performance status of 0 to 2.
• Must have normal organ and bone marrow function based on specific blood tests.
• Women must be post-menopausal or have a negative pregnancy test if they are of childbearing potential.
• Must agree to use effective birth control during the study and for a period after the last dose of treatment.
• Must be willing to comply with study procedures and visits.

Exclusion Criteria

• Cannot be involved in planning or conducting the study.
• Cannot have participated in another clinical study with an investigational product in the last 14 days.
• Cannot have a heart condition with a specific ECG reading (QTc ≥ 470 ms).
• Cannot have had previous treatment with similar immune therapy drugs.
• Cannot have had major surgery within 28 days before starting the study.
• Cannot have received radiation or certain medications within a specified time before the study.
• Cannot have unresolved side effects from previous cancer treatments.
• Cannot have certain lung conditions or active autoimmune diseases, with some exceptions.
• Cannot have a history of organ transplant or certain infections like active hepatitis or HIV.
• Cannot have received a live vaccine within 30 days before the study.
• Cannot have other cancers within the last 5 years, with some exceptions.
• Cannot donate blood during the study or for 90 days after the last treatment.
• Cannot be pregnant or breastfeeding.