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

Phase 2

Completed

• Conditions: Advanced Solid Tumors and Hematological Malignancies; advance solid tumours and blood cancer

• Registration Number: NL-OMON55864
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

• Patients must have pathologically confirmed relapsed or refractory advanced
solid tumour malignancy or haematological malignancies including lymphoma and
acute leukaemia. Any number of prior treatment regimens allowed. A select group
of first-line patients may be eligible for screening and enrolment. These
patients will be enrolled based on investigator assessment as patients for whom
no curative standard of care treatment options exist or such therapies are not
tolerable.
• If available, patients must provide a diagnostic tumor sample taken *3 years
prior to screening for evaluation of PD-L1 status.
• Lansky play performance scale >=50 for patients >=1 and <16 years of age and
Karnofsky performance status score >=50 for patients >=16 years of age (patients
<1 year of age are exempt from this criterion)
• Patients must have measurable/evaluable disease as defined by methods used in
common clinical practice.
• No prior exposure to immune checkpoint inhibitors or genetically engineered
cellular therapies including, but not limited to, other anti- CTLA-4,
anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies and antibodies of CAR-T or other
cell therapies, excluding therapeutic anticancer vaccines.
Exposure to other investigational agents may be permitted after discussion with
the Sponsor or designee.

Exclusion Criteria

• History of allogeneic organ transplantation (exceptions may be allowed for
HL, NHL, ALL and AML, after discussion with Sponsor or designee). Patients who
have previously received an autologous bone marrow transplant may be eligible
• Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease, diverticulitis, celiac disease or other serious GI
chronic conditions associated with diarrhea, systemic lupus erythematosus,
Wegener syndrome; myasthenia gravis, Graves' disease, rheumatoid arthritis,
hypophysitis, uveitis, etc) autoimmune myocarditis, and autoimmune pneumonitis.
The following are exceptions to this criterion:
* Patients with vitiligo or alopecia
* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
* Psoriasis that does not require systemic therapy
* Patients with celiac disease controlled by diet alone.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or
active infection, symptomatic congestive heart failure, cardiac arrhythmia,
ILD, or psychiatric illness or social situations that would
limit compliance with study requirements, substantially increase risk of
incurring AEs from IP, or compromise the ability of the patient to give written
informed consent.
• History of primary immunodeficiency.
• Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV.
Patients with a past or resolved HBV infection are eligible. Patients positive
for hepatitis C virus (HCV) antibody are eligible only if polymerase chain
reaction is negative for HCV ribonucleic acid (RNA).
• Any unresolved toxicity NCI CTCAE version 5.0 Grade >=2 from previous
anticancer therapy with the exception of alopecia, vitiligo, lymphopenia and
the laboratory values defined in the inclusion criteria
* Patients with Grade >=2 neuropathy will be evaluated on a case-bycase basis
and may be included after consultation with the Study Physician.
* Patients with toxicity not reasonably expected to be exacerbated by treatment
with durvalumab or tremelimumab (eg, hearing loss, gastrostomy tube) may be
included after consultation with the Study
Physician.
• Patients with clinically active brain metastases (known or suspected) or
spinal cord compression, and choloromas are excluded, unless these conditions
have been previously treated and are considered stable.
• History of leptomeningeal carcinomatosis, or involvement of any other
anatomic area that, in the opinion of the Investigator, may cause significant
symptoms if an inflammatory reaction occurs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified