NCT01029873

Brief Summary

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
13 years until next milestone

Results Posted

Study results publicly available

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

December 9, 2009

Results QC Date

June 11, 2026

Last Update Submit

August 18, 2026

Conditions

Metastatic Melanoma

Keywords

cancerimmunotherapytargetedmetastaticinterleukin-2IL-2CisplatinantitumormelanomaTCRT-cell receptorp53p53 genep53 tumor suppressor protein

Outcome Measures

Primary Outcomes (4)

  • To Evaluate the Safety of ALT-801-cisplatin Regimen by the Number of Participants With AEs.

    Safety was measured by the number of participants experiencing a treatment emergent adverse event \[AE\]

    Up to 12 months

  • To Assess the Objective Response (OR) Which Includes CR and PR

    The objective response rate (ORR) was calculated as the ratio of the number of patients who demonstrated a confirmed response (complete response \[CR\] or partial response \[PR\]) divided by the number of patients evaluable for response based on Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1, a Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; and Overall Response (OR) = CR + PR.

    3 months

  • To Assess the Clinical Benefit (CB) of the ALT-801-Cisplatin Regimen Which Includes CR, PR and SD

    The clinical benefit rate (CBR) was calculated as the ratio of the number of patients who demonstrated a response (confirmed CR, confirmed PR, or stable disease \[SD\] lasting ≥ 8 weeks) divided by the number of patients evaluable for response.

    3 months

  • To Determine the MTD of the ALT-801-Cisplatin Regimen Determined by Number of Participants With DLTs

    The MTD was determined based on a 3x3 design based on the number of participants with at least 1 Dose Limiting Toxicity (DLT) Adverse Event.

    7 weeks

Secondary Outcomes (2)

  • To Assess the Six-month and One-year Survival Rates.

    12 months

  • Phase 2 Only: To Evaluate the Immunogenicity and Pharmacokinetic Profile of ALT-801

    2 months

Study Arms (4)

ALT-801 - 0.04 mg/kg + cisplatin

EXPERIMENTAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

Drug: CisplatinBiological: ALT-801

ALT-801 - 0.06 mg/kg + cisplatin

EXPERIMENTAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

Drug: CisplatinBiological: ALT-801

ALT-801 - 0.08 mg/kg + cisplatin

EXPERIMENTAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

Drug: CisplatinBiological: ALT-801

ALT-801 - 0.10 mg/kg + cisplatin

EXPERIMENTAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses. Participants received cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

Drug: CisplatinBiological: ALT-801

Interventions

CisplatinDRUG

Participants receive cisplatin 70 mg/m\^2 on cycle 1 day 1 only.

ALT-801 - 0.04 mg/kg + cisplatinALT-801 - 0.06 mg/kg + cisplatinALT-801 - 0.08 mg/kg + cisplatinALT-801 - 0.10 mg/kg + cisplatin
ALT-801BIOLOGICAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg, 0.10 mg/kg) Stage 2: dose expansion (dose at MTD)

ALT-801 - 0.04 mg/kg + cisplatinALT-801 - 0.06 mg/kg + cisplatinALT-801 - 0.08 mg/kg + cisplatinALT-801 - 0.10 mg/kg + cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic melanoma * Measurable * Histologically or cytologically confirmed * Surgically incurable * HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT THERAPY: * If prior Proleukin treatment, must have had clinical benefit * No prior systemic cytotoxic chemotherapy for melanoma * No concurrent radiotherapy, chemotherapy, or other immunotherapy * More than 4 weeks since prior major radiotherapy * More than 8 weeks since prior CTLA-4 antagonist immunotherapy * Not receiving other investigational agents PATIENT CHARACTERISTICS: Life expectancy * \> 3 months Performance status * ECOG 0 or 1 Bone marrow reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL * Platelets ≥100,000/uL * Hemoglobin ≥ 10g/dL Renal function * Serum creatinine ≤ 1.5 mg/dL Hepatic function * Total bilirubin ≤ 1.5 X ULN * AST ≤ 2.5 X ULN * Alkaline phosphatase ≤ 2.5 X ULN * PT INR ≤ 1.5 X ULN * aPTT ≤ 1.5 X ULN Cardiovascular * May be safely tapered off anti-hypertensives if currently on anti-hypertensives * New York Heart Association classification I or II * No congestive heart failure \<6 months * No unstable angina pectoris \<6 months * No myocardial infarction \<6 months * No history of ventricular arrhythmias * Normal cardiac stress test required if any of the following is present: * Age ≥ 50 * History of abnormal EKG * Symptoms of cardiac ischemia or arrhythmia Pulmonary * Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction Other * No known autoimmune disease * No known HIV positive * No psychiatric illness/social situations that would limit study compliance * No history or evidence of CNS disease * No active systemic infection requiring parental antibiotic therapy * No systemic steroid therapy required * No prior organ allograft or allogeneic transplantation * Not receiving chronic medication for asthma * Not pregnant or nursing * Fertile patients must use effective contraception

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Carolinas Medical Center-Brumenthal Cancer Center

Charlotte, North Carolina, 28204, United States

Location

St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

University of Washington, Seattle Cancer Care Center

Seattle, Washington, 98109, United States

Location

Related Links

MeSH Terms

Conditions

MelanomaNeoplasmsNeoplasm Metastasis

Interventions

CisplatinALT-801

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Sandeep Bobby Reddy, Chief Medical Officer
Organization
ImmunityBio
Bobby.Reddy@immunitybio.com
855-797-9277

Study Officials

  • Hing Wong, PhD

    Altor BioScience

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

February 1, 2010

Primary Completion

November 1, 2011

Study Completion

September 1, 2013

Last Updated

September 10, 2026

Results First Posted

September 10, 2026

Record last verified: 2026-07

Locations

US(8)