MelanomaPhase 2NLG2107NCT03301636
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
A Phase 2 study testing Pembrolizumab, Nivolumab and Indoximod in people with Melanoma, run by NewLink Genetics Corporation at 4 sites in United States.
Trial summary
This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Pembrolizumab, Nivolumab and Indoximod
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2017to 4 Nov 2019
- Phase
- Phase 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
- Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
- At least one radiologically measurable lesion as per RECIST 1.1
- Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
- ECOG performance status 0 or 1
- Ability to ingest oral medications
Who cannot join
- Has Ocular Melanoma
- Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
- Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
- Has received prior radiotherapy within 2 weeks of therapy.
- Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Utah Cancer Specialists
Salt Lake City, Utah, 84102
About this study
Official title: A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma
This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial.
The phase 3 study will not proceed per Sponsor decision.
- Conditions
- Melanoma
- Being tested
- Pembrolizumab, Nivolumab, Indoximod
- Keywords
- Melanoma, Metastaic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
NivolumabDrug
Also called Opdivo
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
IndoximodDrug
Indoximod will be administered orally every 12 hours starting at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Indoximiod | Experimental | Not described Receives: Drug: Pembrolizumab; Drug: Indoximod |
| Nivolumab + Indoximiod | Experimental | Not described Receives: Drug: Nivolumab; Drug: Indoximod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start8 Dec 2017
- Primary completion21 Oct 2019
- Study completion4 Nov 2019
Why it stopped: Sponsor termination, not related to efficacy, safety or feasibility.
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.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301636
- Sponsor's protocol ID
- NLG2107
- Acronym
- NLG2107
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2017
- Last updated
- 27 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT03301636
- Acronym / sponsor ID
- NLG2107 / NLG2107
- Conditions
- Melanoma
- Keywords
- Melanoma, Metastaic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor termination, not related to efficacy, safety or feasibility.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial.
The phase 3 study will not proceed per Sponsor decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Indoximiod | Experimental | Drug: Pembrolizumab, Drug: Indoximod |
| Nivolumab + Indoximiod | Experimental | Drug: Nivolumab, Drug: Indoximod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
- At least one radiologically measurable lesion as per RECIST 1.1
- Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
- ECOG performance status 0 or 1
- Ability to ingest oral medications
Key exclusion criteria (7 listed)
- Has Ocular Melanoma
- Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
- Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
- Has received prior radiotherapy within 2 weeks of therapy.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered intravenously every 3 weeks starting on day 1. | Drug | Pembrolizumab + Indoximiod |
| NivolumabAlso: OpdivoNivolumab will be administered intravenously every 2 weeks starting on day 1. | Drug | Nivolumab + Indoximiod |
| IndoximodIndoximod will be administered orally every 12 hours starting at Day 1 | Drug | Nivolumab + Indoximiod, Pembrolizumab + Indoximiod |
Primary outcome
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Nivolumab and Indoximod in people with Melanoma, run by NewLink Genetics Corporation 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Sep 2022. 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 phase mean?
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 27 Sep 2022). 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?
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.