Patients with two or more active malignancies (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ? 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been curatively treated with local therapy)
Assessment of HER2 status in patients with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.
Active second cancers
Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies:
GU cancers with accessible metastases (e.g., bladder, renal)
Other malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only (e.g., localized low-grade cervical or prostate cancers).
Diagnosis of another malignancy within 2 years before the first dose of cabozantinib, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
Diagnosis of another malignancy within 2 years before planned first dose of study drug, except for superficial skin cancers, or localized, low grade tumors
Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
Patients with salivary gland tumors are excluded (patients with nasopharynx CA or sinonasal cancers can participate)
Patients with primary salivary gland cancers are excluded
Patients with known active cancers who are on therapy for those cancers at time of screening
Prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)
Must have select advanced cancers with specific genetic profiles
History of concurrent second cancers requiring active, ongoing systemic treatment.
No other active cancers
Subjects with cytologically or histologically confirmed locally advanced or metastatic HPV associated malignancies including:\r\n* Non-neuroendocrine cervical cancers\r\n* P16+ oropharyngeal cancers\r\n* Anal cancers\r\n* Vulvar, vaginal, penile, squamous cell rectal and neuroendocrine cervical cancers\r\n* Other locally advanced or metastatic solid tumors (e.g. lung, esophagus) that are known HPV+
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)
Patients with known other active cancers; skin cancers (basal or squamous) are exempted
Patients with primary nasopharynx or salivary gland cancers are excluded
Histological confirmation of advanced biliary tract cancers including cancers originating in gallbladder who have received at least one line of systemic anticancer therapy; \r\n* Note: Patients who have either progressed or intolerant to the prior therapy can be included in this study
Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy; malignancy felt by investigator to potentially affect subject survival or ability to evaluate disease response
Cancer survivors of the state of Maryland cancers of interest
Histologically confirmed cancers for which no curative therapy exists.
Prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell carcinoma of the skin, resected T1-2N0M0 differentiated thyroid cancers, invasive cancers with a 3-year disease-free interval, Ta bladder cancers, or low and favorable intermediate risk prostate cancer.
Two or more cancers not resectable through a single lumpectomy incision
Patients with other active cancers receiving anti-cancer agents, with exceptions being hormonal therapy for breast or prostate cancer and skin cancers treated with local therapies only
Current history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the PI
CAPMATINIB EXCLUSION CRITERIA: Diagnosis of concurrent malignancy or previous malignancy within 3 years before study drug administration (exceptions are superficial skin cancers, or any in situ cancers deemed surgically resected, cured and not requiring systemic therapy, and indolent malignancies that currently do not require treatment)
CERITINIB EXCLUSION CRITERIA: Diagnosis of concurrent malignancy or previous malignancy within 3 years before study administration (exceptions are superficial skin cancers, or any in situ cancers deemed surgically resected, cured and not requiring systemic therapy)
Multicentric cancers requiring double lumpectomy
Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured)
History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
Presence of other active invasive cancers that do not harbor CCNE1 amplification
Currently being treated for other cancers with medical or radiation therapy
Presence of other active invasive cancers.
All breast cancers with possibility for surgical excision will be included
Advanced metastatic, progressing carcinoid or pancreatic islet cell cancers
No active second cancers
Other invasive cancers that are clinically active
Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)
Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
Bilateral breast cancers are allowed as long as both cancers are HER2-positive; however, only the primary cancer’s status requires central review
Patients with cancers likely to be Human Papilloma Virus (HPV)-positive such as cervical cancers, oropharyngeal cancers or anal cancers must undergo additional screening to determine eligibility
Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
Patients with a diagnosis of two co-existing primary cancers are excluded
Human papilloma virus-associated cancers basket\r\n* None
Patients with multiple primary cancers
Two or more breast cancers not resectable through a single lumpectomy incision
History of concurrent second cancers requiring active, ongoing systemic treatment.
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Has low-grade or non-epithelial cancers, mucinous cancers, and/or borderline low-malignant potential cancers
Patients with other biliary tract cancers (extrahepatic or gallbladder cancers) with IDH1 or IDH2 mutations are allowed
Diagnosis of another malignancy within 2 years of enrollment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy by the principal investigator
No active second cancers
Prior cancers < 3 years, with the exception of in-situ cervical cancer, low grade prostate cancer and basal or squamous cell skin cancers
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Subjects with simultaneous primary cancers outside of the oropharynx
Patients with BRAF WT cancers
COHORT 1 ONLY: Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Assessment of HER2 status in subjects with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.
Up to 12 patients with incurable Squamous cell cancers as follows:
Current history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the Medical Monitor.
Prior diagnoses of any other type of cancer (excluding some skin cancers)
Other cancers diagnosed within the last 5 years (in situ and/or invasive cancers)
Show no current evidence of disease (NED) for solid-tumor cancers.
Previous diagnosis of grade 1 or 2, stage I or II endometrioid endometrial cancers (“type I cancers”) as confirmed during surgical intervention for treatment
Treatment for solid tumor cancers
Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
History of multiple cancers
Prior cancers allowed if no evidence of disease
Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/ uterine, cervical cancers, and vulvar cancers) undergoing surgical debulking
No active skin cancers; any skin cancers found on the screening visit after the subject has signed consent will need to be treated before the subject begins on the study drug at the baseline visit; the skin cancers found on the screening visit will not be included in the total number of skin cancers the subject had 2 years prior to signing the consent
History of concurrent second cancers requiring active, ongoing systemic treatment.
HER2/neu-negative breast cancers (IHC 0)
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment
PATIENT: Patients with other primary cancers requiring systemic treatment
Fludeoxyglucose F 18 (FDG) avid cancers
Patients with other primary cancers requiring systemic treatment.
Patients with other primary cancers requiring systemic treatment
Patient with advanced skin cancers
No other active cancers
Patients with other primary cancers requiring systemic treatment
Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
Patients currently on chemotherapy or with other primary cancers requiring systemic treatment
Participants with second/other active cancers requiring current treatment