A Phase 2 interventional study of Pembrolizumab and Nivolumab in Melanoma, sponsored by NewLink Genetics Corporation. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by NewLink Genetics Corporation · Phase 2, Interventional, and Treatment
Among 2,048 studies in Melanoma with a site in United States — 243 open to participants now, 439 under way, 32 of them phase 3. Melanoma · United States.
Among the 2,048 studies in Melanoma with a site in United States, this one is the 1,164th largest by enrollment of the 1,748 interventional ones that give a count, is one of 85 that started in 2017, is one of 612 in phase 2, and was the 1,318th registered.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
Browse Melanoma studies →243 of the 2,048 studies in Melanoma with a site in United States are open now. Recruiting first, the newest first:
Children's Oncology Group · Sites in United States
John Kirkwood · Sites in United States
University of Wisconsin, Madison · Sites in United States
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
University of Colorado, Denver · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 467 Melanoma studies recruiting now, 380 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,048 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 934 · Phase 2 907 · Phase 3 115 · Phase 4 11
First in 1991; this study’s year is marked. 85 started in 2017.
This study's enrollment of 21 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.
Median enrollment 37 across the 1,748 interventional studies, 156 across the 212 observational. Of the 1,481 that completed or were terminated, 598 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
799 of 2,048 have an industry lead sponsor. The 10 most frequent:
NewLink Genetics Corporation is the lead sponsor of 34 studies on the registry; none are open to participants now.
NewLink Genetics Corporation has 6 studies filed under Melanoma — fewer than ten, so there is no comparison to draw.
141 of the studies in Melanoma with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT05987332Phase 3IDEAYA BiosciencesIDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma | 2027-01-15 |
| NCT06246916Phase 3Regeneron PharmaceuticalsA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | 2027-03-22 |
| NCT01223248Phase 3Memorial Sloan Kettering Cancer CenterRandomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy | 2027-10 |
| NCT06112314Phase 3Immunocore LtdIMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | 2027-10-16 |
Among the 2,048 studies in Melanoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pembrolizumab · Drug: Indoximod
Drug: Nivolumab · Drug: Indoximod
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
Also known as: Keytruda
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
Also known as: Opdivo
Indoximod will be administered orally every 12 hours starting at Day 1
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Time frame: 28 Days
| Milestone | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|
| Started | 7 | 6 | 8 |
| Completed | 7 | 6 | 8 |
| Not completed | 0 | 0 | 0 |
| Participants | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|
| Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | 1 | 1 | 0 |
Collected over All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1 | 2/7 (28.6%) | 0/7 (0%) | 7/7 (100%) |
| Dose Level 2 | 0/6 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| Dose Level 3 | 2/7 (28.6%) | 3/7 (42.9%) | 7/7 (100%) |
| Event | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 0/7 | 1/6 | 0/7 |
| Aspartate aminotransferase increasedInvestigations | 0/7 | 1/6 | 0/7 |
| Haemorrhage intracranialNervous system disorders | 0/7 | 0/6 | 1/7 |
| HeadacheNervous system disorders | 0/7 | 0/6 | 1/7 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/7 | 0/6 | 1/7 |
| Event | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|
| HypertensionVascular disorders | 3/7 | 3/6 | 6/7 |
| FatigueGeneral disorders | 4/7 | 1/6 | 4/7 |
| PruritusSkin and subcutaneous tissue disorders | 2/7 | 3/6 | 1/7 |
| RashSkin and subcutaneous tissue disorders | 2/7 | 2/6 | 3/7 |
| NauseaGastrointestinal disorders | 2/7 | 2/6 | 3/7 |
| DiarrhoeaGastrointestinal disorders | 3/7 | 2/6 | 1/7 |
| HeadacheNervous system disorders | 3/7 | 2/6 | 2/7 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/7 | 1/6 | 0/7 |
| InsomniaPsychiatric disorders | 1/7 | 2/6 | 1/7 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/7 | 2/6 | 2/7 |
| Age, Continuous(years) | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|
| Mean | 60.3 ± 15.14 | 61.8 ± 14.77 | 61.9 ± 8.22 | 61.3 ± 12.15 |
| Sex: Female, Male(Participants) | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|
| Female | 4 | 3 | 5 | 12 |
| Male | 3 | 3 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 7 | 6 | 8 | 21 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Height(Centimeters) | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|
| Mean | 171.3 ± 10.56 | 168.8 ± 8.86 | 172.9 ± 10.25 | 171.1 ± 9.59 |
| Weight(Kilograms) | Dose Level 1 | Dose Level 2 | Dose Level 3 | Total |
|---|---|---|---|---|
| Mean | 102.77 ± 22.3 | 75.12 ± 13.009 | 117.44 ± 26.960 | 100.46 ± 27.502 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Oct 2019, 22 months.
Results were first posted in Sep 2022, 2 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Indoximod
NewLink Genetics Corporation →