NCT03012620

Who might be able to join this trial:

• You have signed a consent form agreeing to take part in the study.
• You have been diagnosed (confirmed by tissue testing) with one of the specific rare cancers covered by this trial, which include certain rare sarcomas, rare ovarian cancers, a type of brain/eye lymphoma (PCNSL), rare thyroid cancers, certain neuroendocrine tumours, germ-cell cancers, or a specific type of T-cell lymphoma — the exact types accepted may have changed partway through the trial, so confirm your specific diagnosis with the trial site.
• Your cancer has spread or cannot be removed by surgery, and it has not responded to standard treatments, or no standard treatment exists or is considered suitable for you.
• You are aged 18 or older (or aged 15 or older if joining the rare sarcoma group).
• Your cancer can be measured on scans or through specific blood markers, according to standard medical guidelines.
• You are able to provide a tissue sample (biopsy) from your tumour — either from stored samples or a new biopsy, unless this is not medically safe.
• At least 21 days have passed since your last cancer treatment before starting the trial.
• Any side effects from previous cancer treatments have mostly resolved to a mild level before starting the trial (except for some hair loss, which is allowed).
• Your blood counts are at an acceptable level, tested within 14 days of starting treatment (confirm details with trial site).
• Your kidneys are working well enough, tested within 14 days of starting treatment (confirm details with trial site).
• Your liver is working well enough, tested within 14 days of starting treatment (confirm details with trial site).
• Your blood calcium and magnesium levels are completely normal, tested within 14 days of starting treatment.
• You are generally well enough to carry out light activity and care for yourself (a standard medical fitness score of 0 or 1).
• Your life expectancy is estimated to be at least 90 days.
• If you are sexually active, you must agree to use effective contraception during the trial and for several months afterwards (at least 5 months for women, 7 months for men).
• If you could become pregnant, you must have a negative pregnancy test within 72 hours before starting treatment.
• If you are breastfeeding, you must stop before starting treatment and for at least 120 days after the last dose.
• You must be enrolled in a Social Security system or equivalent health coverage.

Who may not be able to join:

• You have previously been treated with a type of immunotherapy drug called an anti-PD-1 or anti-PD-L1 antibody.
• You are eligible for, and willing to join, another clinical trial for your cancer that is currently open in France.
• You are currently taking steroid medication above a certain dose (confirm the specific dose limit for your situation with the trial site).
• You have an active autoimmune disease that has needed systemic treatment in the past 2 years (routine hormone replacement therapy is generally not counted as this type of treatment — confirm with trial site).
• You have a history of serious lung inflammation (pneumonitis) that needed steroid treatment, or you currently have this condition.
• You have had a severe allergic reaction to any monoclonal antibody therapy in the past.
• You have received radiotherapy (other than to the brain or limbs) within 21 days before starting the trial.
• You have taken part in another clinical trial or received an experimental drug within 21 days before starting this trial.
• You have active, symptomatic cancer spread to the brain — though previously treated and stable brain metastases may be acceptable (confirm with trial site).
• You have cancer that has spread to the membranes surrounding the brain or spinal cord, unless you have primary CNS lymphoma.
• Your kidney function is below the required level based on blood tests (confirm details with trial site).
• You have had another cancer in the past 5 years, other than a common type of non-melanoma skin cancer or early-stage cervical cancer.
• You have a serious active infection currently requiring antibiotic or antimicrobial treatment.
• You have active hepatitis B, hepatitis C, HIV, or a known history of active tuberculosis.
• You have received a live vaccine within 30 days before starting treatment (standard inactivated flu vaccines are generally