Non-small Cell Lung CancerPhase 1/2NCT02523469
ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1/2 study testing ALT-803 and Nivolumab in people with Non-small Cell Lung Cancer, run by Medical University of South Carolina at 4 sites in United States.
Trial summary
The purpose of the study is to define the safety and tolerability of this drug combination. The study will also define the response rate of patients with advanced and unresectable NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- ALT-803 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jan 2016to 24 Feb 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) or recurrent disease following radiation therapy or surgical resection.
- Patient must be eligible for treatment with nivolumab. Patients previously treated with nivolumab, pembrolizumab or atezolizumab, and who have progressed are eligible.
- Patients with targetable with EGFR or ALK mutations are eligible after disease recurrence or progression after at least one targeted therapy for advanced or metastatic disease.
- Measurable disease as defined by RECIST 1.1 criteria.
- Age ≥ 18 years
- Performance status: ECOG performance status of ≤1 (Appendix A)
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- Adequate organ system function within 14 days of registration:
- ANC ≥ 750/μL (≥0.75 X 109/L) PLT ≥ 100,000/μL (≥ 30 X 109/L) HGB > 8g/dL Total bilirubin < 2.0 x ULN AST < 3.0 X ULN ALT < 3.0 X ULN eGFR > 45mL/min
- using Cockcroft \& Gault equation (see Appendix B)
- Negative serum pregnancy test if WOCBP (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
- Female participants of childbearing potential must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study. WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment.
- Prior to any study specific activities, the patient must be aware of the nature of his/her disease and willingly consent to the study after being informed of study procedures, the experimental therapy, possible alternatives, risks and potential benefits.
Who cannot join
- While prior therapy with nivolumab, pembrolizumab, or atezolizumab is allowed, any prior therapy with other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) is not allowed.
- NYHA Class III or IV heart failure (Appendix C), uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction.
- Symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months of registration.
- Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds).
- Patients with CNS metastases with the following exceptions: Patient untreated CNS metastases with 5 or fewer sites of disease, with no single site larger than 20mm, are eligible if they are asymptomatic and not requiring steroids at any dose. Patients with asymptomatic CNS metastases may be treated with radiosurgery before or during therapy on trial without treatment delays. Patients with treated, symptomatic CNS metastases are eligible if they are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to registration AND either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of registration are excluded. Inhaled or topical steroids, and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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- Subjects with a history of interstitial lung disease and/or pneumonitis.
- Known HIV-positive.
- Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Positive hepatitis C serology or active hepatitis B infection. Chronic asymptomatic viral hepatitis is allowed.
- Women who are pregnant or nursing.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Any ongoing toxicity from prior anti-cancer treatment that, in the judgment of the investigator, may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (NCI CTCAE version 4) or baseline prior to registration.
- Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration.
- Other illness that in the opinion of the investigator would exclude the patient from participating in this study, including uncontrolled diabetes mellitus, cardiac disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
University of Minnesota
Minneapolis, Minnesota, 55455
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Phase IB/II Study of Nivolumab In Combination With ALT-803 In Patients With Pretreated, Advanced, or Metastatic Non-Small Cell Lung Cancer
The purpose of the study is to define the safety and tolerability of this drug combination. The study will also define the response rate of patients with advanced and unresectable NSCLC.
Read the detailed description
This study has a dose escalation (Ib) and dose expansion phase (II). The ALT-803 treatment in the Phase Ib portion of the study will escalate until a recommended dose level is decided. This dose level will be used in the phase II portion of the study. The Phase II potion of the study will include two groups: Nivolumab naive and Nivolumab progressing. Patients will be enrolled to one of the arms based on their previous treatment with Nivolumab.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ALT-803, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-803Biological
ALT-803 administered IV at doses per arm (6, 10, 15, 20 µg/kg)
NivolumabBiological
Also called OPDIVO
Nivolumab administered IV at 3 mg/kg per protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg | Experimental | Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol Receives: Biological: ALT-803; Biological: Nivolumab |
| Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg | Experimental | Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol Receives: Biological: ALT-803; Biological: Nivolumab |
| Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg | Experimental | Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol Receives: Biological: ALT-803; Biological: Nivolumab |
| Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) | Experimental | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV per protocol Receives: Biological: ALT-803; Biological: Nivolumab |
| Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) | Experimental | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population Receives: Biological: ALT-803; Biological: Nivolumab |
| Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) | Experimental | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure Receives: Biological: ALT-803; Biological: Nivolumab |
| Exploratory Arm 1 | No intervention | ALT-803 ± Nivolumab for biomarker analysis only |
| Exploratory Arm 2 | No intervention | ALT-803 ± Nivolumab for biomarker analysis only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab
A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients
Measured: Cycles 1-4: Weeks 1-6 of each cycle
Objective Response Rate
The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer.
Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Measured: While on study, at the end of each 6 week cycle; if off study, every 3 months, UP TO 3 YEARS
Secondary outcomes (3)
Progression-Free Survival (PFS)
Time from randomization to disease progression or death.
Measured: Up to 6 months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from first dose of study treatment until death from any cause. Participants without a death event at the time of data cutoff were censored at the date of last known survival status.
Measured: From first dose until death or last known alive, up to 15 months.
Duration of Response (DoR)
Duration of Response (DoR) was defined as the time from the first documented objective response (CR or PR) until disease progression or death. Participants who had not progressed or died at the time of the data cutoff were censored at the date of last adequate tumor assessment. DoR was evaluated only in participants who achieved an objective response.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start8 Jan 2016
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Altor BioScience
- Responsible party
- Sponsor
- Investigators
- John Wrangle, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523469
- Sponsor's protocol ID
- 102323
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2015
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wrangle JM, Velcheti V, Patel MR, Garrett-Mayer E, Hill EG, Ravenel JG, Miller JS, Farhad M, Anderton K, Lindsey K, Taffaro-Neskey M, Sherman C, Suriano S, Swiderska-Syn M, Sion A, Harris J, Edwards AR, Rytlewski JA, Sanders CM, Yusko EC, Robinson MD, Krieg C, Redmond WL, Egan JO, Rhode PR, Jeng EK, Rock AD, Wong HC, Rubinstein MP. ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer: a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2018 May;19(5):694-704. doi: 10.1016/S1470-2045(18)30148-7. Epub 2018 Apr 5.
PubMed 29628312
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Study of Nivolumab In Combination With ALT-803 In Patients With Pretreated, Advanced, or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02523469
- Acronym / sponsor ID
- 102323
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Altor BioScience
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to define the safety and tolerability of this drug combination. The study will also define the response rate of patients with advanced and unresectable NSCLC.
Detailed description
This study has a dose escalation (Ib) and dose expansion phase (II). The ALT-803 treatment in the Phase Ib portion of the study will escalate until a recommended dose level is decided. This dose level will be used in the phase II portion of the study. The Phase II potion of the study will include two groups: Nivolumab naive and Nivolumab progressing. Patients will be enrolled to one of the arms based on their previous treatment with Nivolumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population |
| Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) | Experimental | Biological: ALT-803, Biological: NivolumabParticipants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure |
| Exploratory Arm 1 | No intervention | –ALT-803 ± Nivolumab for biomarker analysis only |
| Exploratory Arm 2 | No intervention | –ALT-803 ± Nivolumab for biomarker analysis only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) or recurrent disease following radiation therapy or surgical resection.
- Patient must be eligible for treatment with nivolumab. Patients previously treated with nivolumab, pembrolizumab or atezolizumab, and who have progressed are eligible.
- Patients with targetable with EGFR or ALK mutations are eligible after disease recurrence or progression after at least one targeted therapy for advanced or metastatic disease.
- Measurable disease as defined by RECIST 1.1 criteria.
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- While prior therapy with nivolumab, pembrolizumab, or atezolizumab is allowed, any prior therapy with other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) is not allowed.
- NYHA Class III or IV heart failure (Appendix C), uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction.
- Symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months of registration.
- Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds).
- Patients with CNS metastases with the following exceptions: Patient untreated CNS metastases with 5 or fewer sites of disease, with no single site larger than 20mm, are eligible if they are asymptomatic and not requiring steroids at any dose. Patients with asymptomatic CNS metastases may be treated with radiosurgery before or during therapy on trial without treatment delays. Patients with treated, symptomatic CNS metastases are eligible if they are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to registration AND either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALT-803ALT-803 administered IV at doses per arm (6, 10, 15, 20 µg/kg) | Biological | Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve), Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor), Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg, Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg, Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg, Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) |
| NivolumabAlso: OPDIVONivolumab administered IV at 3 mg/kg per protocol | Biological | Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve), Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor), Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg, Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg, Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg, Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) |
Primary outcome
Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab
Time frame: Cycles 1-4: Weeks 1-6 of each cycle
A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients
Objective Response Rate
Time frame: While on study, at the end of each 6 week cycle; if off study, every 3 months, UP TO 3 YEARS
The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer. Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 6 months
Overall Survival (OS)
Time frame: From first dose until death or last known alive, up to 15 months.
Duration of Response (DoR)
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29628312Wrangle JM, Velcheti V, Patel MR, Garrett-Mayer E, Hill EG, Ravenel JG, Miller JS, Farhad M, Anderton K, Lindsey K, Taffaro-Neskey M, Sherman C, Suriano S, Swiderska-Syn M, Sion A, Harris J, Edwards AR, Rytlewski JA, Sanders CM, Yusko EC, Robinson MD, Krieg C, Redmond WL, Egan JO, Rhode PR, Jeng EK, Rock AD, Wong HC, Rubinstein MP. ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer: a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2018 May;19(5):694-704. doi: 10.1016/S1470-2045(18)30148-7. Epub 2018 Apr 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wrangle, MD principal investigator
Medical University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALT-803 and Nivolumab in people with Non-small Cell Lung Cancer, run by Medical University of South Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab (time frame: Cycles 1-4: Weeks 1-6 of each cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.