Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02363283
• Date of registration: 13/02/2015
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
• Scientific title: A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma
• Date of first enrolment: September 16, 2015
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02363283
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sapna Patel
• Affiliation: University of Texas MD Anderson Cancer Center LAO

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic or locally
recurrent uveal melanoma; because histologic or cytologic confirmation of primary
uveal melanoma is not always possible, confirmation of the clinical diagnosis of uveal
melanoma by the treating investigator is allowed; clinical diagnosis of uveal melanoma
is often made by an ophthalmologist, not by tissue diagnosis; if an ophthalmologist
diagnosed and treated a patient for uveal melanoma in the past, it is sufficient for a
clinical diagnosis

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded for
non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with
conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT)
scan, magnetic resonance imaging (MRI), or calipers by clinical exam

- The study will be limited to patients who are chemotherapy naive; patients may have
received prior systemic or liver-directed local therapies for advanced uveal melanoma
as long as those treatments do not involve chemotherapy; this includes, but is not
limited to: immunotherapy, targeted therapy, transarterial embolization,
radiofrequency ablation, or cryoablation; treatment must be completed at least 28 days
prior to initiation of study therapy; radiation therapy is also allowed and must be
completed at least 28 days prior to initiation of study therapy; lesions treated via
radiation or liver-directed therapy may not be used as target lesions unless they
demonstrate growth over a minimum of 3 months on subsequent imaging

- All prior treatment-related toxicities must be Common Terminology Criteria for Adverse
Events (CTCAE) version (V) 5 grade =< 1 (except alopecia); certain exceptions apply,
such as immunotherapy-induced hypothyroidism or adrenal insufficiency or
panhypopituitarism requiring stable doses of hormone replacement or rash from prior
therapy

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Life expectancy of greater than 3 months

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin =< 1.5 x institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal; =< 5 x institutional upper limit of
normal if liver metastasis present

- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for 4 months after last CDX-011
(glembatumumab vedotin) dose; women of child-bearing potential must have a negative
serum pregnancy test within 14 days prior to start of protocol treatment; should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately; men
and women treated or enrolled on this protocol must also agree to use adequate
contraception prior to the study, for the duration of study participation, and 4
months after completion of glembatumumab vedotin administration

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with a history of another malignancy except for those who have been
disease-free for 2 years; patients with a history of definitively treated non-melanoma
skin cancer or squamous cell carcinoma of the cervix are eligible; patients with
definitively treated in-situ cancers are eligible, regardless of timeframe

- Patients with neuropathy > grade 1

- Patients who are receiving any other investigational agents; if the patient received a
previous investigational or other agent or treatment, a washout period of 4 weeks is
required

- Patients receiving any medications or substances that are substrates of cytochrome
P450 family 3, subfamily A, polypeptide 4 (CYP3A4) will be closely monitored for
toxicity; as part of the enrollment/informed consent procedures, the patient will be
counseled on the risk of interactions with other agents, and what to do if new
medications need to be prescribed or if the patient is considering a new
over-the-counter medicine or herbal product

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Human immunodeficiency virus (HIV)-positive patients on antiretroviral medications
that are CYP3A4 substrates will be closely monitored; HIV-positive patients will be
excluded if they have a cluster of differentiation 4 (CD4) count < 200

- Pregnant or nursing women

- Patients who have previously received CDX-011 (glembatumumab vedotin) or other
monomethyl auristatin E (MMAE)-containing agents

- Patients with a history of allergic reactions attributed to compounds of similar
composition to dolastatin or auristatin (e.g. Auristatin PHE, Auristatin PE, and
symplostatin)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stage IV Uveal Melanoma AJCC v7

Recurrent Uveal Melanoma

Intervention(s)

Drug: Glembatumumab Vedotin

Other: Pharmacological Study

Other: Laboratory Biomarker Analysis

Primary Outcome(s)

Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 [Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years and 10 months]

Secondary Outcome(s)

The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry [Time Frame: Baseline to up to 21 days]

Progression-free Survival [Time Frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months]

Overall Survival [Time Frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months]

Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 [Time Frame: through 30 days post-treatment, up to 2 years and 10 months]

Secondary ID(s)

NCI9855

UM1CA186712

NCI-2015-00159

N01CM00039

9855

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02363283