Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cemiplimab · 29 trials · 44 indications
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
Successful conversion to resectable disease must meet all of the following criteria: * Absence of extra-regional lymph node metastases, including retropancreatic or paraceliac lymph node involvement * Absence of invasion of the portal vein or main hepatic artery * Absence of extrahepatic organ tumor invasion, except for contiguous involvement of the diaphragm * Absence of bilobar liver involvement, including bilateral bile duct involvement to the secondary radicles * If right or left hepatic lobe atrophy, absence of contralateral secondary biliary radicle involvement * Absence of disseminated metastatic disease * Adequate estimated liver remnant after surgery (This may be achieved with portal vein embolization.) * Tumor resected.
The primary endpoint is 6-month disease control rate (DCR). The analysis will be conducted in the FAS population. DCR is defined as the proportion of patients who have achieved at 6 months an overall response of CR, PR or stable disease (SD), as assessed by an independant review committee (IRC) per RECIST v1.1 modified for mesothelioma.
Comparison of the 1-year progression-free survival between patients with oligo-metastatic ccRCC treated with cemiplimab alone versus those treated with both cemiplimab and fianlimab following SBRT.
Rate of clinical complete response after 4 cycles of neoadjuvant chemoimmunotherapy. Complete clinical response will be defined as: * No high-grade malignancy on repeat TURBT * No malignant cells on urine cytology * No definitive evidence of invasive local or metastatic disease on cross-sectional imaging (CT chest, abdomen, and pelvis with contrast or, if renal dysfunction, MRI with contrast) Cytoscopy and imaging should occur within 4 weeks of end of neoadjuvant therapy.
Defined by responders at surgery using clinical assessment and RECIST v1.1. Results will be summarized with frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (max two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes \<10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or the appearance of new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
Defined responders plus stable disease using clinical assessment and RECIST v1.1. Results will be summarized by frequency counts, percentages, and exact Clopper-Pearson 95% CIs. Tumor response will follow RECIST v1.1: up to five target lesions (no more than two per organ) measured by longest diameter (non-nodal) or short axis (nodal). Complete Response is disappearance of all target lesions and lymph nodes \<10 mm. Partial Response is ≥30% decrease from baseline. Progressive Disease is ≥20% increase (and ≥5 mm growth) from the smallest on-study sum or new lesions. Stable Disease applies when changes do not meet PR or PD. Reasons for unevaluable cases will be documented.
ORR is defined as the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR will be assessed according to RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
MPR is defined as ≤ 10% viable tumor cells in resected tumor after complete evaluation in the resected lung cancer specimen as determined by central pathology review and described by IASLC 2020 assessment criteria. The measure of interest is the proportion of treated patients with ≤ 10% residual viable tumor cells within all resected tissue as confirmed by the central pathology review.
PFS6 as defined from the time of treatment start to the time of progression (based on clinical assessment and imaging per Immunotherapy Response Assessment in Neuro-Oncology (iRANO)) or death, whichever is earlier, or last follow-up if neither progression nor death event is observed. PFS6 will be estimated as the empirical PFS probability at Month 6 using the Kaplan-Meier method.
OS as defined from the time of treatment start to the time of death or last follow up if surviving; OS-18 is further estimated as the empirical OS probability at Month 18 using the Kaplan-Meier method.
Cohorts A1, A2, A3
Cohort B, B2, B3
Cohort C
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
The incidence of DLTs evaluated in Phase Ib: considered as the rate of patients who experience adverse events (AE) and treatment-related AEs (TRAEs) assessed by NCI CTCAE v5.0 which may be considered DLTs.
Relapse-Free Survival (RFS) rate at 3 years evaluated in Phase II study. 3-years RFS rate is defined as the percentage of patients free of locoregional progression or recurrence or new basocellular tumors, distant metastasis (RECIST v 1.1) or death due to any cause after 3 years from the date of study treatment. Patients not presenting any of the previous events will be censored at the date of last assessment. RFS will be summarized using the Kaplan-Meier method and displayed graphically where appropriate. The Cox proportional hazards model will be fitted to compute the hazard ratios on potential stratified groups if applicable. RFS will be calculated as median / mean (95% CI) for each cohort and RFS rate for different timepoints as applicable.The primary endpoint will be assessed locally and centrally. Central assessment will be prioritized for the primary endpoint.
The dose-limiting toxicity (DLT) will be the basis for safety and toxicity of Cemiplimab -TP that will be measured and reported only during the first cycle of Cemiplimab -TP for the first 6 study objects in each cohort A and B since the majority of the DLT occurs after the first treatment cycle in multiple phase I oncology clinical trials. DLTs must be related to a study drug, cemiplimab. Known and expected chemotherapy (TP, standard of care) adverse events not related to cemiplimab will not be defined as DLTs.
The proportions of patients who have observed GVHD in Cohort 1 or renal transplant rejection in Cohort 2. Participants will be evaluable for from the time of their first treatment.
Part 1a
Part 1a
Part 1a
Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion.
Phase 1b
Part A
Part A and B
Dose levels 1-3
Dose levels 1-3
Peak serum concentration
Time to Cmax
Drug concentration in serum at the end of a dosing interval
AUC over a 3-week dosing interval
Observed terminal half-life
| Arm | Type | Description |
|---|---|---|
| Experimental Arm | EXPERIMENTAL | - |
| Control Arm | OTHER | - |
| Cemiplimab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Experimental Therapy | EXPERIMENTAL | Cemiplimab |
| Control Therapy | ACTIVE_COMPARATOR | Investigator choice (IC) chemotherapy |
| Standard-of-care chemotherapy | ACTIVE_COMPARATOR | Standard-of-care chemotherapy will administered from these options: Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance |
| Arm A: cemplimab + chemotherapy | OTHER | cemplimab 350mg administered every 3 weeks for up to 24 months, with pemetrexed 500 mg/m² + platinum salt (cisplatin 75 mg/m² or carboplatin AUC 5) for 6 cycles of 21 days. |
| Arm B: cemplimab + fianlimab + chemotherapy | EXPERIMENTAL | cemplimab 350mg and fianlimab 1600mg administered every 3 weeks for up to 24 months, with pemetrexed 500 mg/m² + platinum salt (cisplatin 75 mg/m² or carboplatin AUC 5) for 6 cycles of 21 days. |
| Cemiplimab + Fianlimab | EXPERIMENTAL | Cemiplimab, 350 mg, IV, and Fianlimab 1600 mg, IV, q3w for 1 year. Patients will undergo treatment with the study drug(s) every 3 weeks for a maximum of 17 cycles (approximately 12 months) or until disease recurrence, unacceptable toxic effects, or intercurrent illness preventing further administration. |
| Group 1: Gemcitabine/Cisplatin/Cemiplimab | EXPERIMENTAL | * Gemcitabine 1000 mg/m\^2 IV (days 1 and 8 of 21 day for 4 cycles) * Cisplatin 70 mg/m\^2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose -cisplatin 35 m/m\^2 IV (day 1 and 8 of 21 day cycle for 4 cycles) * Cemiplimab (REGN 2810) 350 mg IV every 3 weeks (17 cycles) |
| Group 2: Gemcitabine/Cisplatin/Cemiplimab/Fianlimab | EXPERIMENTAL | * Gemcitabine 1000 mg/m2 IV (days 1 and 8 of 21 day cycle for 4 cycles) * Cisplatin 70 mg/m2 IV (day 1 of 21 day cycle for 4 cycles) or renally-dosed split-dose cisplatin 35 m/m2 IV (day 1 and 8 of 21 day cycle for 4 cycles ) * Cemiplimab (REGN 2810) 350mg IV every 3 weeks (4 cycles) * Fianlimab (REGN3767) 1600mg IV every 3 weeks (4 cycles) |
| Cohort 1: Cemiplimab | EXPERIMENTAL | Patients will undergo 2 infusions of Cemiplimab (Cemi), 350 mg every 3 weeks. Patients undergo CT or MRI scans and collection of blood samples throughout the trial. Patients also undergo biopsies during screening and on study. The recommended dose of Cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks (constituting one cycle). Dosing will occur in this manner for a single dose of 350mg Cemiplimab every 3 weeks constituting 1 cycle of therapy. Patients will undergo at least 2 cycles of Cemiplimab and at most, 4 additional cycles dependent upon treatment response. |
| Cohort 2: Fianlimab + Cemiplimab | EXPERIMENTAL | Patients will undergo infusions of Cemiplimab (C) and Fianlimab (F), 350 mg Cemiplimab + 1600 mg Fianlimab every 3 weeks. Fianlimab in combination with cemiplimab can be administered to patients in a sequential order through co-administration, or concurrently via a fixed-dose combination (FDC). When the FDC is used, the drug product containing co-formulated drugs in a vial is injected into the IV bag and delivered intravenously to the patient. FDC of fianlimab 1600 mg + cemiplimab 350 mg will be administered as a single infusion over 30 to 40 minutes every 3 weeks (constituting one cycle). Patients will undergo at least 2 cycles of the FDC and at most, 4 additional cycles dependent upon treatment response. |
| Standard immunosuppression + Cemiplimab + Cetuximab (optional) | EXPERIMENTAL | Patients will receive standardized immunosuppression (sirolimus and prednisone) lead-in treatment for 7 to 14 days prior to starting treatment with cemiplimab. Cemiplimab is given IV on Day 1 of every 21-day cycle for a maximum of 24 months. Sirolimus is continued during cemiplimab, and dynamic prednisone is continued for the first 6 cycles. If patient progresses during treatment with cemiplimab, patients will be offered cetuximab as salvage therapy at the investigator's discretion and will be administered according to standard of care (SOC). |
| Treatment with Cemiplimab | EXPERIMENTAL | Cemiplimab 350 mg IV administered every 3 weeks Will be given for at least 3 pre-operative doses, with potential 4th dose pending interim radiographic assessment after cycle 2 of treatment. |
| Experimental Arm: LiTT + Cemiplimab | EXPERIMENTAL | Patients in the Experimental Arm will receive adjuvant cemiplimab (at a dose of 350 mg intravenously (IV)) every 3 weeks after LiTT for a maximum total of 36 months (or until disease progression or intolerable adverse event). The first adjuvant dose of cemiplimab must be given within 14 days post-LiTT. |
| Control Arm: LiTT + adjuvant chemotherapy | ACTIVE_COMPARATOR | Patients in the Control Arm will undergo LiTT, then will receive adjuvant chemotherapy (chosen by their treating physician) for up to 12 months as per standard of care (SOC), starting within 14 days post-LiTT. |
| Chemotherapy+Cemiplimab | ACTIVE_COMPARATOR | Control treatment |
| Arm 1: Chemotherapy+Cemiplimab+REGN7075 | EXPERIMENTAL | Investigational Treatment |
| Arm A | ACTIVE_COMPARATOR | As described in the protocol |
| Arm B | EXPERIMENTAL | As described in the protocol |
| Arm C | EXPERIMENTAL | As described in the protocol |
| Cemiplimab+ISA101b | EXPERIMENTAL | - |
| Cohort A1 | EXPERIMENTAL | Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort A2 | EXPERIMENTAL | Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort A3 | EXPERIMENTAL | Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort B | EXPERIMENTAL | Cemiplimab prior to surgery; cemiplimab post surgery (HCC) |
| Cohort C | EXPERIMENTAL | Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual |
| Cohort B2 | EXPERIMENTAL | SBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC) |
| Cohort B3 | EXPERIMENTAL | Cemiplimab and fianlimab before and after surgery (HCC) |
| Group 1- metastatic BCC | EXPERIMENTAL | Administration of cemiplimab in accordance with protocol dosing regimen |
| Group 2 - unresectable locally advanced BCC | EXPERIMENTAL | Administration of cemiplimab in accordance with protocol dosing regimen |
| Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W | EXPERIMENTAL | Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles). |
| Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W | EXPERIMENTAL | Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles). |
| Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W | EXPERIMENTAL | Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles). |
| Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W | EXPERIMENTAL | Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles). |
| Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W | EXPERIMENTAL | Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles). |
| Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W | EXPERIMENTAL | Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles). |
| Cohort 1: cemiplimab neoadjuvant treatment | ACTIVE_COMPARATOR | Patients will be treated with single agent intravenous cemiplimab 350 mg every 3 weeks for a total of 4 neoadjuvant cycles (12 weeks). |
| Cohort 2: cemiplimab plus topical imiquimod (plus fractional laser therapy) as neoadjuvant | EXPERIMENTAL | Patients will be treated with intravenous cemiplimab 350 mg every 3 weeks in combination with topical imiquimod 5% cream self-applied once daily 5 days per week (plus low-intensity laser therapy at 1- or 3-week interval), for a total of 4 neoadjuvant cycles (12 weeks). |
| Cohort A | EXPERIMENTAL | * 3 cycles of Cemiplimab-TP induction chemotherapy will be delivered in cohort A. * Cemiplimab-TP chemotherapy will be given every 21 days starting on days 1, 22 and 43, etc. (+ 2 days) with TP given on days 1, 22, and 43 (+/- 2 days) and Cemiplimab given on days 14, 35, 56 (+/- 2 days). * Patients in cohort A will get 3 doses of Cemiplimab during induction therapy. |
| Cohort 1 Cemiplimab | EXPERIMENTAL | Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days |
| Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone | EXPERIMENTAL | Participants who received a kidney transplant will receive * Cemiplimab via IV, flat predetermined dosage every 21 days * Everolimus or Sirolimus-least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab * Prednisone 40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapering doses while receiving Cemiplimab |
| Phase 1 Arm A | EXPERIMENTAL | Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab |
| Phase 1 Arm B | EXPERIMENTAL | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
| Phase 2 | EXPERIMENTAL | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
| Dose Escalation | EXPERIMENTAL | 27T51 monotherapy |
| Dose Expansion - Arm A | EXPERIMENTAL | 27T51 monotherapy |
| Dose Expansion - Arm B | EXPERIMENTAL | 27T51+Cemiplimab |
| Dose Expansion - Arm C | EXPERIMENTAL | 27T51+Cemiplimab+Bevacizumab |
| Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab | EXPERIMENTAL | Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment. |
| Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab | EXPERIMENTAL | Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A. |
| Cohort D | EXPERIMENTAL | Part 2 |
| Cohort E | EXPERIMENTAL | Part 2 |
| Dose escalation phase | EXPERIMENTAL | Safety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab. |
| Dose expansion phase | EXPERIMENTAL | RP2D administration of the combination treatment. |
| Monotherapy Cohort | EXPERIMENTAL | Cemiplimab will be administered alone |
| Dual Combination Cohorts | EXPERIMENTAL | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy Doses of cemiplimab will be administered in combination with Cyclophosphamide Doses of cemiplimab will be administered in combination with Docetaxel |
| Triple Combination Cohorts | EXPERIMENTAL | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel |
| Quadruple Combination Cohorts | EXPERIMENTAL | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide |
| Name | Type | Description |
|---|---|---|
| Cemiplimab | DRUG | Administered per protocol |
| Standard of care | PROCEDURE | Primary surgery |
| Placebo | DRUG | Intravenous (IV) infusion over 30 minutes |
| Investigator Choice (IC) Chemotherapy | DRUG | IC chemotherapy options include: 1. Antifolate: Pemetrexed 2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan 3. Nucleoside analogue: Gemcitabine 4. Vinca alkaloid: Vinorelbine The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above. |
| Pemetrexed | DRUG | Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin |
| Paclitaxel | DRUG | Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin |
| Gemcitabine | DRUG | Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin |
| Cisplatin | DRUG | Administered with either Pemetrexed, Paclitaxel or gemcitabine. |
| Carboplatin | DRUG | Administered with either Pemetrexed, Paclitaxel or gemcitabine. |
| Fianlimab | DRUG | 1600mg every 3 weeks for up to 24 months. |
| Pemetrexed (Alimta) | DRUG | 500 mg/m² every 3 weeks for 6 cycles. |
| Carboplatin (AUC 5) | DRUG | AUC 5 (recommended maximum dose of 800 mg) every 3 weeks for 6 cycles. |
| Cemiplimab 350 MG Intravenous Solution | DRUG | Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology. By binding to PD-1, cemiplimab (Libtayo) has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. |
| Fianlimab 1600 MG Intravenous Solution | DRUG | Fianlimab is a recombinant fully human monoclonal antibody (based on IgG4 isotype) targeting the immune checkpoint receptor LAG-3 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology. |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Biospecimen Collection | PROCEDURE | Undergo collection of blood samples |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Biopsy | PROCEDURE | Undergo biopsy |
| Prednisone | DRUG | Prednisone is administered orally and taken about the same time each day. Prednisone will be pulsed for Cycles 1-6 and continued to be pulsed or dose reduced for Cycles 7+. For Cycles 1-6: 40 mg dose will be administered the day before each cycle (Day -1 or Day 21) and Days 1-3, 20mg dose Days 4-6, and 10mg dose Days 7-20. For Cycles 7+: Dose will be administered pulsed as Cycles 1-6 or 10mg daily |
| Sirolimus | DRUG | Sirolimus will be taken orally once daily at dose prescribed to achieve a goal trough level of 4-6 ng/mL. It should be taken around the same time daily. Sirolimus will be administered daily throughout each cycle. |
| Cetuximab (EGFR inhibitor) | DRUG | Cetuximab may be administered according to standard of care (SOC). |
| NeuroBlate® Laser Ablation Laser Interstitial Thermal Therapy | DEVICE | LiTT, or magnetic resource imaging (MRI)-guided laser ablation, is a minimally invasive surgery approved for cytoreductive treatment of brain tumors. It employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MRI imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. |
| Chemotherapy | DRUG | Adjuvant chemotherapy will be decided by the physician's choice of best fit by patient, including the agent(s), dosing, and schedule. |
| Platinum-based chemotherapy | DRUG | IV infusion |
| REGN7075 | DRUG | IV infusion |
| Fixed Dose Combination (FDC) cemiplimab+fianlimab | DRUG | Or coadministration, depending on availability. |
| ISA101b | BIOLOGICAL | Administered by subcutaneous (SC) injection on day 1, day 29, and day 50 |
| Platinum Doublet | DRUG | Administered intravenous (IV) |
| Topical imiquimod | DRUG | Topical imiquimod 5% cream self-applied once daily 5 days per week (plus low-intensity laser therapy at 1- or 3-week interval), |
| Docetaxel | DRUG | 75 mg/2 intravenous infusion over 60 minutes, mixed as described in Schedule: Day 1, every 21days (+ 2 days) |
| Everolimus | DRUG | Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab |
| Cemiplimab+Fianlimab Fixed Dose Combination (FDC) | DRUG | Administered per the protocol |
| 27T51 | OTHER | Intravenous (IV) infusion |
| Bevacizumab | DRUG | IV Infusion |
| 89Zr˗DFO˗REGN5054 | DRUG | Administered by intravenous (IV) infusion during Part A and B. |
| Ipilimumab | DRUG | To be administered per protocol |
| Platinum-doublet chemotherapy | DRUG | To be administered per protocol |
| odronextamab | DRUG | Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol. |
| Hypofractionated radiotherapy | RADIATION | - |
| Cyclophosphamide | DRUG | - |
| GM-CSF | DRUG | - |
Key Inclusion Criteria: 1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol 2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and \>0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pr...
Cemiplimab is an investigational oncology drug being studied for epithelial ovarian cancer, advanced malignancies, non-small-cell lung carcinoma, pleural mesotheliomas, cutaneous squamous cell carcinoma, and in kidney transplant recipients. It is a small molecule PDCD1 inhibitor being developed by Regeneron Pharmaceuticals, Inc. (REGN).
Cemiplimab targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, the drug is designed to modulate immune responses in oncology settings. This mechanism is being evaluated across multiple cancer types including melanoma, renal cell carcinoma, and pleural mesothelioma.
Cemiplimab is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting clinical trials of cemiplimab both as a monotherapy and in combination with fianlimab across various oncology indications.
Cemiplimab is in Phase 1 clinical development overall, though individual trials range from Phase 2 to Phase 3. A Phase 3 trial in cervical cancer is completed, while active Phase 2 trials are studying the drug in melanoma and clear cell renal cell carcinoma. The drug remains investigational and is not approved.
Cemiplimab is being studied in four clinical trials. NCT03257267 is a completed Phase 3 trial in cervical cancer. NCT06190951 is an active Phase 2 trial in melanoma. NCT07223541 is a recruiting Phase 2 trial in clear cell renal cell carcinoma. NCT07234058 is a not-yet-recruiting Phase 2 trial in pleural mesothelioma.
Cemiplimab is also known as cemiplimab plus fianlimab in fixed-dose combination form, and as cemiplimab 350 MG intravenous solution. The drug is studied both alone and combined with fianlimab, depending on the trial. Alternative names include cemiplimab+fianlimab and cemiplimab plus gemcitabine.