Solid Tumors Clinical Trials
Exact Sciences 2018-01
Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Solid Tumors
Jessicca Rosario, BS
Treatment Agent: N/A
Synopsis: You are being asked to take part in a research study being conducted by Exact Sciences for subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor.
The purpose of this research is to collect blood samples to better understand the biomarkers of patients with breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer. Biomarkers are biologic features found in the blood and may be related to cancer risk and detection.
- Subject is male or female > 18 years of age.
- Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
Subject has suspicion of a primary malignancy of bladder, kidney/renal pelvis, or ovarian cancer based on imaging.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
- Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
- Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors
Treatment Agent: Cabozantinib, Atezolizumab
Synopsis: You are being asked to take part in this clinical research study because you have one of the following types of cancer: urothelial carcinoma (includes cancer of the bladder, urethra, ureter, and renal pelvis), renal cell carcinoma (kidney cancer), castration-resistant prostate cancer (CRPC), non-squamous non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric/gastroesophageal junction cancer (GC/GEJC), colorectal cancer (CRC), head and neck (H&N) cancer, or differentiated thyroid cancer (DTC). You may have already received standard of care treatment(s) for your cancer and you are no longer benefiting from your recent treatment. If you haven’t received standard of care treatment for your cancer, your doctor will inform you about treatment alternatives before you decide to take part in this study. If you join this study, you will receive a combination of cabozantinib (XL184) and atezolizumab. If you have been diagnosed with urothelial carcinoma or NSCLC and treated with immune checkpoint inhibitor therapy before joining the study, you will either receive the combination therapy of cabozantinib with atezolizumab or cabozantinib alone.
Cabozantinib is an oral anticancer agent which is approved in the United States and in other countries including those in the European Union. Cabozantinib tablets are approved to treat patients with advanced renal cell carcinoma. In addition, cabozantinib is currently being studied in clinical trials for the treatment of multiple cancers, including your type of cancer. Cabozantinib is considered an investigational drug because it has not been approved by any regulatory authorities (including US Food and Drug Administration [FDA]) for use in any cancer types other than RCC to be evaluated in this study. To date, cabozantinib has been generally well tolerated in cancer patients at doses at or above the doses used in this study.
Atezolizumab is a drug given by intravenous (IV) infusion, which is approved in the United States and in the European Union for advanced urothelial carcinoma as initial or later treatment. It is also approved for the treatment of patients with advanced NSCLC who progressed after certain prior therapies. In addition, atezolizumab is currently being studied in clinical trials for the treatment of multiple cancers, including your type of cancer. Atezolizumab is considered an investigational drug because it has not been approved by any regulatory authorities (including US Food and Drug Administration [FDA]) for use in any cancer types other than UC and NSCLC to be evaluated in this study. To date, atezolizumab has been generally well tolerated in cancer patients at a dose used in this study.
- Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
- Dose-Escalation Stage:
- Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or
- Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
- Expansion Stage:
- Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC, CRC, H&N cancer, and DTC as outlined above)
- Dose-Escalation Stage:
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Tumor tissue material available (archival or recent tumor biopsy)
- Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Age eighteen years or older on the day of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ and marrow function.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screening.
- Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7,19 and 20. Other restrictions regarding prior therapy may apply.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
- Concomitant anticoagulation with oral anticoagulants.
- Subject is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
- The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
- Pregnant or lactating females.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Diagnosis of another malignancy within 2 years before first dose of study treatment.
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER)
Treatment Agent: TSR-022 and TSR-042
Synopsis: You are being asked to be in this research study because you have a type of cancer that cannot be removed by surgery and it has grown on or after your latest anti-cancer treatment.
Purpose: To look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller and to see if it is safe and well tolerated in patients with advanced solid tumors; to confirm how much TSR-022 should be given and how often when taken by itself; and to confirm how much TSR-022 should be given and how often it should be taken when given with TSR-042 as Combination Drug.
- Female patients must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of nonchildbearing potential.
- Female patients of childbearing potential (see above) and male patients must agree to use 2 adequate methods of contraception with their partner
- ECOG performance status of ≤ 1
- Adequate hematologic and organ function
- For Part 1a: anti-CTLA-4, anti-PD-1, anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent within 3 weeks (ie, 21 days) prior to initiation of study treatment
- For Parts 1b and 1c: anti-CTLA-4 within 3 weeks (ie, 21 days) prior to initiation of study treatment, prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
- For Part 2 combination arm (TSR-022 + TSR-042): prior treatment with anti-PD-1, anti- PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
- Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Other serious, uncontrolled medical disorders including, but not limited to nonmalignant systemic disease or active infection requiring systemic therapy, immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV 1/2 antibodies, known active hepatitis B , active autoimmune disease, history of interstitial lung disease, history of ≥ Grade 3 immune-related AE with prior immunotherapy with the exception of non-clinically significant lab abnormalities.
- Pregnant or breast feeding, or expecting to conceive children within the projected duration of the study
- Not recovered (ie, to ≤ Grade 1 or to baseline) from treatment-related AEs