Clinical Trial Information
Protocol: Alliance – A031702
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:
– One measurable site of disease as per RECIST v1.1
– One bone lesion on bone scan (tec99 or NaF PET/CT, CT or MRI) for the bone-only
– Histologically confirmed diagnosis of metastatic: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC.
– H&E slides from diagnostic tumor tissue for retrospective central pathology review.
- Patients may have received any number of prior anti-cancer treatments or be treatment naïve (with the exception of patients with small cell carcinoma of the bladder, whom should have received a platinum-based combination regimen either as
neoadjuvant, adjuvant or first-line treatment).
- Age ≥18 years.
- Patients must be able to swallow oral formulation of the tablets.
- Karnofsky performance status ≥70%.
- Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not
- Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4/CTLA-4 inhibitors is allowed, either in the perioperative or in the metastatic setting. However, patients that have received both prior MET or VEGF and prior PD-1/PDL1/CTLA-4 (sequentially or in combination) are not allowed.
- The patient has received no radiation therapy:
– To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy.
– To brain metastasis within 3 weeks for WBXRT, and 2 weeks for SBRT before the first dose of study treatment.
– To any other site(s) within 2 weeks before the first dose of study treatment.
- The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving Gonadotropin-releasing hormone
(GnRH) agonists and antagonists are allowed to participate.
- The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment.
- The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are
asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain
imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.
- No history of major surgery as follows:
– Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed postsurgery.
– Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement.
– Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery.