Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). FDA label
Also known as INCMGA0012, ZYNYZ, INCMGA00012, MGA 012, Retifanlimab-dlwr
Retifanlimab · 20 trials · 44 indications
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Overall survival was defined as the time between the date of randomization and the date of death due to any cause.
The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.
DFS is defined the occurrence of progression of local disease, distant metastases, second primary or death. 1-year DFS, will be analyzed using the Kaplan-Meier method and be compared using a 0.05-level one-sided two-proportion test. DFS will be compared among the three subgroups: favorable response subgroup, intermediate response subgroup, unfavorable response subgroup.
Defined as the proportion of participants having a best objective response of complete response (CR) or partial response (PR), as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Objective radiographic response (ORR), as measured by modified Response Assessment in Neuro-Oncology (RANO) criteria. ). The response is classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).
PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.
RNA expression analysis (Nanostring) to determine changes in Interferon gamma expression signature before and during treatment
Flow cytometry to determine changes in immune infiltrate in the tumor before and during treatment
Multicolor immunohistochemstry to determine changes in immune infiltrate in the tumor before and during treatment
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Will be determined by the number, frequency, duration, and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0; laboratory tests and vital signs.
Radiographic response rates in target tumors according to tumor-associated criteria: * VS, non-VS, and meningiomas: Dombi criteria (2013) * Ependymomas: RECIST 1.12
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Dose Limiting Toxicities DLTs Adverse Events The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Treatment related Dose Limiting Toxicities (DLTs) will be monitored through the first 2 cycles of the study therapy (28 days). Follow up safety assessments will continue beyond the first 28 days and throughout the treatment on the trial to monitor for late onset treatment related adverse effects or toxicities
* Safety will be defined as a \< 33% treatment-related DLT rate related to vaccination alone or in combination with retifanlimab, by the end of the DLT observation period for a given cohort. * A DLT will be defined as any grade 3 toxicity or greater according to CTCAE v5 considered at least possibly related to study treatment (exceptions are listed in the protocol). * The DLT observation period begins with date of first vaccine administration and continues for 30 days from administration of first dose of retifanlimab. For patients in Cohort A, this is Day 87 (first dose of retifanlimab is given with vaccine Dose 3 on Day 57), and for patients in Cohort B, this is Day 30 (first dose of retifanlimab is given with vaccine Dose 1 on Day 1).
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Maximum Tolerated Dose of INCMGA00012
| Arm | Type | Description |
|---|---|---|
| Group A : carboplatin+paclitaxel+placebo | PLACEBO_COMPARATOR | Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle |
| Group B : carboplatin+paclitaxel+retifanlimab | EXPERIMENTAL | Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle |
| INCMGA00012 + chemotherapy (nonsquamous NSCLC) | EXPERIMENTAL | INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression. |
| Placebo + chemotherapy (nonsquamous NSCLC) | ACTIVE_COMPARATOR | Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
| INCMGA00012 + chemotherapy (squamous NSCLC) | EXPERIMENTAL | INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression. |
| Placebo + chemotherapy (squamous NSCLC) | ACTIVE_COMPARATOR | Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
| Interventional arm | EXPERIMENTAL | Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. |
| Chemoradiation based on HPV ctDNA response | EXPERIMENTAL | All participants will receive CRT for one cycle (4 weeks), while undergoing HPV ctDNA testing. Investigators will then modify the treatment plan based on HPV ctDNA response: * Favorable response: Dose reduction (total of 28 fractions of CRT) * Intermediate response: Standard dose (total of 30 fractions of CRT) * Unfavorable response: Dose-intensification (total of 34 fractions of CRT) and Retifanlimab to follow CRT |
| Treatment (retifanlimab, tuparstobart, and verzistobart) | EXPERIMENTAL | INDUCTION PHASE: Patients receive retifanlimab IV over 30 minutes every 4 weeks and tuparstobart and verzistobart IV over 30 minutes every 2 weeks. Treatment continues for up to day 169 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography CT/MRI during screening and on study and blood sample collection on study and may undergo during screening. Patients may also undergo a tumor biopsy during screening and on study. MAINTENANCE PHASE: Patients receive retifanlimab, tuparstobart and verzistobart IV over 30 minutes every 6 weeks. Treatment continues for up to day 715 in the absence of disease progression or unacceptable toxicity. Patients undergo CT/MRI on study and blood sample collection on study and may undergo during follow-up. Patients may also undergo tumor biopsy on study and during follow-up. |
| Arm A (failed prior TMZ + one other alkylating chemotherapy) | EXPERIMENTAL | Subjects in Arm A are alkylator-refractory and at high risk for progression of disease, have failed temozolmide and another alkylating agent. Subjects in Arm A will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1. |
| Arm B (failed only one prior alkylating chemotherapy) | EXPERIMENTAL | Subject in Arm B are patients who have failed only one prior alkylating chemotherapy regimen and have gone at least 12 months since the last treatment. Subjects in Arm B will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1. |
| Arm C (surgical arm, ATRA alone pre-operatively) | EXPERIMENTAL | Subject in Arm C will receive ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery, then undergo surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1. |
| Arm D (surgical arm, ATRA + retifanlimab pre-operatively) | EXPERIMENTAL | Subject in Arm D will receive the combination of ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery plus a 500mg IV dose of retifanlimab 14 days prior to the date of surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1. |
| Treatment Group 1: Retifanlimab Monotherapy | EXPERIMENTAL | Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks. |
| Treatment Group 2: Retifanlimab + INCAGN02385 | EXPERIMENTAL | Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks. |
| Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 | EXPERIMENTAL | Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks. |
| Capecitabine, oxaliplatin and retifanlimab | EXPERIMENTAL | IV and PO Capecitabine 1000 mg/m2, oxaliplatin 130 mg/m2, every three weeks (up to 2 cycles) IV retifanlimab 500mg, every four weeks |
| Group A - retifanlimab | EXPERIMENTAL | Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously |
| Group B - retifanlimab | EXPERIMENTAL | Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously |
| Group C - retifanlimab + epacadostat | EXPERIMENTAL | Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor) |
| Group D - retifanlimab + pemigatinib | EXPERIMENTAL | Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor) |
| Group E - retifanlimab + epacadostat | EXPERIMENTAL | Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat |
| Group F - retifanlimab + INCAGN02385 and INCAGN02390 | EXPERIMENTAL | Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously |
| Treatment (pelareorep, retifanlimab) | EXPERIMENTAL | Patients receive pelareorep IV over 60 minutes on days 1, 2, 15, and 16. Patients also receive INCMGA00012 IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Cohort A | EXPERIMENTAL | Subjects in this arm (N=16) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Cohort B sub-arm #1 | EXPERIMENTAL | Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Cohort B sub-arm #2 | EXPERIMENTAL | Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Sub-study A (brigatinib) - CLOSED TO ENROLLMENT | EXPERIMENTAL | Subjects treated in this arm will receive brigatinib 90 mg by mouth daily for 7 days and then increased to 180 mg by mouth daily if the drug is tolerated. |
| Sub-study B (neratinib) | EXPERIMENTAL | The first three participants treated in this arm will receive neratinib 200 mg mg by mouth daily. If these participants tolerate the medication well, subsequent participants will receive neratinib 240 mg by mouth daily. |
| Experimental: sub-study C (retifanlimab plus bevacizumab) | EXPERIMENTAL | Subjects on this arm will receive retifanlimab by IV infusion at a dose of 375 mg every 3 weeks on a continuous schedule for 48 weeks. Subjects will also receive bevacizumab by IV infusion at a dose of 7.5 mg/kg every 3 weeks on an intermittent schedule. One cycle last 42 days and the study will last for 52 total weeks (48 treatment weeks and 4 follow-up weeks). |
| Retifanlimab: Chemotherapy: Naïve | EXPERIMENTAL | - |
| Retifanlimab: Chemotherapy: Refractory | EXPERIMENTAL | - |
| Melanoma: retifanlimab 500 mg | EXPERIMENTAL | Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle. |
| NSCLC: retifanlimab 500 mg | EXPERIMENTAL | Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle. |
| UC: retifanlimab 500 mg | EXPERIMENTAL | Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle. |
| RCC: retifanlimab 500 mg | EXPERIMENTAL | Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle. |
| Retifanlimab 500 mg | EXPERIMENTAL | Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W). |
| Retifanlimab + 9-ING-41 + Chemotherapy | EXPERIMENTAL | 1. Chemotherapy: oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, irinotecan 150 mg/m2 IV, and 5-FU continuous IV infusion 2400 mg/m2 over 46 hours every 14 days 2. Retifanlimab: IV at 500 mg on day 1 of every other cycle (Cycles 1, 3, 5, etc) 3.9-ING-41: IV at 9.3 mg/kg twice weekly (days 1, 3, 8 and 11) for the first 4 cycles, then weekly (days 1 and 8) thereafter |
| Cohort A: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort A will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection alone during the first two priming doses, then concurrently with retifanlimab during the subsequent boosting doses (Doses 3 through 6) * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| Cohort B: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort B will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection plus concurrent retifanlimab beginning with Dose 1 and continuing for a total of 6 doses. * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| INCMGA00012 | EXPERIMENTAL | Single-agent INCMGA00012. |
| INCB001158 75 mg | EXPERIMENTAL | Single-agent INCB001158. |
| INCB001158 100 mg | EXPERIMENTAL | Single-agent INCB001158. |
| INCMGA00012 + INCB001158 | EXPERIMENTAL | Combination of INCMGA00012 and INCB001158. |
| Group A | EXPERIMENTAL | INCMGA00012 with epacadostat. |
| Group B | EXPERIMENTAL | INCMGA00012 with INCB050465. |
| Dose Escalation-Q2W | EXPERIMENTAL | INCMGA00012 treatment once every 2 weeks. |
| Dose Escalation- Q3W | EXPERIMENTAL | INCMGA00012 treatment once every 3 weeks. |
| Dose Escalation- Q4W | EXPERIMENTAL | INCMGA00012 treatment once every 4 weeks. |
| Expansion Cohort | EXPERIMENTAL | INCMGA00012 treatment for locally advanced or metastatic solid tumors. |
| Name | Type | Description |
|---|---|---|
| carboplatin | DRUG | carboplatin will be administered intravenous on Day 1 of each 28 day cycle |
| paclitaxel | DRUG | paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle |
| retifanlimab | DRUG | retifanlimab will be administered intravenous on Day 1 of each 28 day cycle |
| Placebo | DRUG | Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
| Pemetrexed | DRUG | Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle. |
| Cisplatin | DRUG | Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| nab-Paclitaxel | DRUG | nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles. |
| HPV ctDNA Response based radiation | RADIATION | Total radiation doses per response group: * Favorable response: 5040 cGy in 28 fractions * Intermediate response: 5400 cGy in 30 fractions * Unfavorable response: 6120 cGy in 34 fractions |
| Chemotherapy | DRUG | 1. Mitomycin-C(MMC) 12 mg/m2 on day 1 AND one of the following: 2. Capecitabine 825 mg/m2 twice daily on all days of radiotherapy for all response groups OR 5-Fluorouracil: 1000 mg/m²/day as a continuous infusion for 96 hours on days 1-4 and 29-32 |
| Biopsy | PROCEDURE | Undergo tumor biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Computed Tomography | PROCEDURE | Undergo CT/MRI |
| Magnetic Resonance Imaging | PROCEDURE | Undergo CT/MRI |
| Tuparstobart | DRUG | Given IV |
| Verzistobart | DRUG | Given IV |
| All-trans retinoic acid | DRUG | All-trans retinoic acid (ATRA) 45mg/m2 orally in two equally divided doses on days 1-14 of each 28-day cycle, continued until disease progression, unacceptable toxicity, or 2 years from the first dose of study medication, whichever occurs first. |
| INCAGN02385 | DRUG | INCAGN02385 350mg will be administered intravenously every 2 weeks. |
| INCAGN02390 | DRUG | INCAGN02390 400 mg will be administered intravenously every 2 weeks. |
| Capecitabine | DRUG | PO Capecitabine |
| Oxaliplatin | DRUG | IV Oxaliplatin |
| epacadostat | DRUG | epacadostat will be administered orally BID. |
| pemigatinib | DRUG | pemigatinib will be administered orally QD. |
| Pelareorep | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
| INCMGA00012 | DRUG | 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment |
| INCAGN01876 | DRUG | 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment |
| SRS | DRUG | administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). |
| Brain surgery | PROCEDURE | maximal safe surgical resection of the tumor. |
| Brigatinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Neratinib | DRUG | Oral daily per predetermined dosage per protocol. |
| Bevacizumab | DRUG | Every 3 weeks by IV per predetermined dose in protocol. |
| 9-ING-41 | DRUG | a maleimide-based ATP-competitive and selective glycogen synthase kinase-3β (GSK-3β) inhibitor with an IC50 of 0.71 μM. 9-ING-41 significantly leads to cell cycle arrest, autophagy and apoptosis in cancer cells |
| Personalized Neoantigen DNA vaccine | BIOLOGICAL | The sites of immunization may be rotated for each of the immunizations. |
| TDS-IM v 2.0 electroporation device | DEVICE | Each DNA vaccination will be 1 mL vaccine administered intramuscularly using an integrated electroporation administration system |
| INCB001158 | DRUG | Part 1: INCB001158 75 or 100 mg twice daily administered orally. |
| Retifanlimab + INCB001158 | DRUG | Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 . |
| INCB050465 | DRUG | Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1. |
Inclusion Criteria: * Able to comprehend and willing to sign a written ICF for the study. * Are 18 years of age or older (or as applicable per local country requirements). * Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC. * No prior systemic therapy...
Retifanlimab is an investigational monoclonal antibody being developed by Incyte Corporation for the treatment of advanced solid tumors and other cancers. It is designed as a PDCD1 antagonist and is being studied across tumor types including anal cancer, endometrial cancer, gastric adenocarcinoma, glioma, and breast cancer. It is not yet approved and remains in clinical development.
Retifanlimab is being studied for advanced solid tumors, including anal cancer, anatomic stage IV breast cancer, endometrial cancer, gastric adenocarcinoma, and glioma. Clinical trials also evaluate it in Merkel cell carcinoma, glioblastoma, and pancreatic adenocarcinoma. It is investigational and has not been approved for any indication.
Retifanlimab targets PDCD1, also known as PD-1, and acts as an antagonist of that receptor. By blocking PDCD1, the antibody is intended to interfere with a checkpoint pathway that tumors use to suppress immune responses. This mechanism places retifanlimab in the immune checkpoint inhibitor class of oncology therapies.
Retifanlimab is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor associated with the clinical development program for this monoclonal antibody across multiple solid tumor indications.
Retifanlimab is in clinical development, with studies spanning Phase 1 and Phase 2. It is investigational and has not been approved by the FDA. Trials include a Phase 1 study in pancreatic adenocarcinoma and Phase 2 studies in anal cancer and Merkel cell carcinoma.
Retifanlimab is being evaluated in several trials, including NCT07425054 in locally advanced anal cancer, NCT06896188 in advanced pancreatic adenocarcinoma, NCT06056895 in PD-(L)1 refractory Merkel cell carcinoma, and NCT05743595 in newly diagnosed unmethylated glioblastoma. These studies are recruiting or active but not recruiting, and enrollment ranges from 12 to 33 patients each.