Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

NOT ENROLLING
Protocol # :
19-116
Conditions
Pediatric Cancer
Solid Tumor Pediatric
Hematological Malignancies
Phase
I/II
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Other Hematopoietic
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Leukemia, other
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Collins, Natalie, B
Site Research Nurses
Aspri, Tristan
Cavanaugh, Kerri, Lynn
Ezrre, Suzanne

Trial Description

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab
(immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and
expand in a second phase to test the efficacy of these drugs once this dose is determined.

Eligibility Requirements

Inclusion Criteria:

- Max Age =17 years

- Solid Tumors (except primary central nervous system malignant tumors): Patients must
have a histopathologic confirmation of malignancy. Patients must have progressed or
are refractory to standard therapies, and for whom no standard of care treatments
exist

- Non-Hodgkin's Lymphoma, limited to primary mediastinal B-cell lymphoma and anaplastic
large cell lymphoma. Patients must have progressed or are refractory to standard
therapies, and for whom no standard of care treatments exist.

- Provision of diagnostic tumor sample mandated if available

- Evaluable disease

- No prior exposure to immune-mediated therapy

- Adequate organ and marrow function

- Life expectancy of at least 3 months

Exclusion Criteria:

- History of allogeneic organ transplantation (exceptions may be allowed for NHL after
discussion with Sponsor). History of autologous bone marrow transplant may be allowed
(after discussion with Sponsor).

- Active or prior documented autoimmune or inflammatory disorders (exceptions)

- Uncontrolled intercurrent illness

- History of primary immunodeficiency

- Active infection including tuberculosis, hepatitis B, C or HIV

- Any unresolved toxicity NCI CTCAE version 5.0 Grade ≥2 from previous anticancer
therapy (exceptions)

19-116