This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.
This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
Yash Choksi, MD
- Assistant Professor of Medicine (Gastroenterology, Hepatology, and Nutrition)
This phase II trial investigates how well sacituzumab govitecan and atezolizumab work in preventing triple negative breast cancer from coming back (recurrence). Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the bodys natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help the immune system identify and catch tumor cells. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called SN-38. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers SN-38 to kill them. Giving sacituzumab govitecan and atezolizumab may work as a treatment for residual cancer in the breast or lymph nodes.
Langerhans Cell Histiocytosis
- Langerhans cell histiocytosis is a rare disorder that can damage tissue or cause lesions to form in one or more places in the body.
- It is not known whether LCH is a form of cancer or a cancer-like disease.
- Family history of cancer or having a parent who was exposed to certain chemicals may increase the risk of LCH.
- The signs and symptoms of LCH depend on where it is in the body.
- Bone
- Skin and nails
- Mouth
- Lymph nodes and thymus
- Endocrine system
- Eye
- Central nervous system (CNS)
- Liver and spleen
- Lung
- Bone marrow
- Tests that examine the organs and body systems where LCH may occur are used to diagnose LCH.
- Certain factors affect prognosis (chance of recovery) and treatment options.
Osteosarcoma and Malignant Fibrous Histiocytoma of Bone
- Osteosarcoma and undifferentiated pleomorphic sarcoma (UPS) of bone are diseases in which malignant (cancer) cells form in bone.
- Having past treatment with chemotherapy or radiation can increase the risk of osteosarcoma.
- Signs and symptoms of osteosarcoma and UPS include swelling over a bone or a bony part of the body and joint pain.
- Imaging tests are used to detect (find) osteosarcoma and UPS.
- A biopsy is done to diagnose osteosarcoma.
- Certain factors may affect prognosis (chance of recovery) and treatment options.
Ewing Sarcoma
- Ewing sarcoma is a type of tumor that forms in bone or soft tissue.
- Undifferentiated round cell sarcoma may also occur in the bone or soft tissue.
- Signs and symptoms of Ewing sarcoma include swelling and pain near the tumor.
- Tests that examine the bone and soft tissue are used to diagnose and stage Ewing sarcoma.
- A biopsy is done to diagnose Ewing sarcoma.
- Certain factors affect prognosis (chance of recovery).
Extracranial Germ Cell Tumors
- Childhood extracranial germ cell tumors form from germ cells in parts of the body other than the brain.
- Childhood extracranial germ cell tumors may be benign or malignant.
- Childhood extracranial germ cell tumors are grouped as gonadal or extragonadal extracranial tumors.
- Gonadal germ cell tumors
- Extragonadal extracranial germ cell tumors
- There are three types of extracranial germ cell tumors.
- Teratomas
- Malignant germ cell tumors
- Mixed germ cell tumors
- The cause of most childhood extracranial germ cell tumors is unknown.
- Having certain inherited disorders can increase the risk of extracranial germ cell tumors.
- Signs of childhood extracranial germ cell tumors depend on where the tumor formed in the body.
- Imaging studies and blood tests are used to diagnose childhood extracranial germ cell tumors.
- Certain factors affect prognosis (chance of recovery) and treatment options.
Central Nervous System Germ Cell Tumors
- Childhood central nervous system (CNS) germ cell tumors form from germ cells.
- There are different types of childhood CNS germ cell tumors.
- Germinomas
- Nongerminomas
- Teratomas
- The cause of most childhood CNS germ cell tumors is not known.
- Signs and symptoms of childhood CNS germ cell tumors include unusual thirst, frequent urination, or vision changes.
- Imaging studies and other tests are used to help diagnose childhood CNS germ cell tumors.
- A biopsy may be done to be sure of the diagnosis of a CNS germ cell tumor.
- Certain factors affect prognosis (chance of recovery).
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients.
