Percutaneous hepatic injection of rose bengal disodium (PV-10) in metastatic uveal melanoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3143-3143 ◽  
Author(s):  
Sapna Pradyuman Patel ◽  
Brett W. Carter ◽  
Ravi Murthy ◽  
Rahul Sheth ◽  
Sanjiv S. Agarwala ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Uveal Melanoma ◽  
Phase 1 ◽  
Unmet Need ◽  
Standard Of Care ◽  
Complete Response ◽  
Immune Checkpoint Blockade ◽  
Open Label ◽  
Open Label Phase ◽  
Hepatic Lesions

3143 Background: PV-10 is a small molecule autolytic immunotherapy in clinical development for treatment of solid tumors. When administered by intralesional (IL) injection, PV-10 can produce immunogenic cell death that may induce a T cell-mediated immune response against treatment refractory and immunologically cold tumors. Given this mechanism of action and clinical data that metastatic uveal melanoma (MUM) generates low response rates to immune checkpoint blockade (CB), we investigated treatment of MUM with percutaneously-delivered PV-10. Methods: This open-label Phase 1 basket study (NCT00986661) is evaluating the safety, tolerability, and preliminary efficacy of intralesional PV-10 in patients (pts) with solid tumors of the liver. PV-10 is injected into one or more designated hepatic tumor(s) with a maximum sum of diameters ≤4.9 cm. Response assessments using 2D EASL criteria are performed at Day 28, then every 3 months. Pts with additional injectable tumors are eligible to receive further PV-10 after Day 28. Pts can receive standard of care CB immunotherapy during treatment with PV-10. Results: As of February 1, 2020, the initial cohort of 15 pts with MUM to the liver was fully enrolled. Pts had received at least 1 IL injection of PV-10, with an average of 2 hepatic lesions injected per pt (range 1-4). Of these, 4 pts were refractory to prior CB. Three pts received PV-10 alone, 3 received PV-10 + anti-PD-1 and 9 received PV-10 + anti-PD-1 + anti-CTLA-4. Adverse events (AEs) were consistent with established patterns for PV-10 and CB: AEs attributed to PV-10 were transient and included 3 cases of Grade 3/4 transaminitis that resolved within 72 hrs, injection site pain, photosensitivity, and pink discoloration of skin, urine or feces; AEs attributed to CB included nausea, decreased WBC, and fatigue. Response assessments on 24 injected tumors were: 2 complete response (8%), 7 partial response (29%) and 11 stable disease (46%), per 2D EASL. Among the 4 CB-refractory pts, median overall survival (OS) was 9.2 months (range 5.3 - 11.4 months, with 2 pts alive at 5.3 months each), while among the 11 CB-naïve pts OS was undefined (range 0.5 - 21.9+ months, with 1 death at 7.9 months). Pts receiving PV-10 alone (1 CB-refractory, 2 naïve) achieved a median OS of 7.9 months with one CB-naïve pt alive with partial overall response at 21.9 months. Conclusions: Response indicative of regression or stabilization in a majority (83%) of injected lesions is encouraging in a disease of major unmet need. Enrollment and follow-up for safety, duration of response and survival are ongoing. Clinical trial information: NCT00986661 .

scholarly journals A first-in-human, phase 1 study of the NEDD8 activating enzyme E1 inhibitor TAS4464 in patients with advanced solid tumors

2021 ◽  
Author(s):  
Noboru Yamamoto ◽  
Toshio Shimizu ◽  
Kan Yonemori ◽  
Shigehisa Kitano ◽  
Shunsuke Kondo ◽  
...  
Keyword(s):  
Liver Function ◽  
Solid Tumors ◽  
Dose Escalation ◽  
Enzyme Inhibitor ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Open Label ◽  
Phase 1 Study ◽  
Open Label Phase

SummaryBackground This open-label, phase 1 study investigated TAS4464, a potent NEDD8-activating enzyme inhibitor, in patients with advanced/metastatic solid tumors (JapicCTI-173,488; registered 13/01/2017). The primary objective was dose-limiting toxicities (DLTs). Maximum-tolerated dose (MTD) was investigated using an accelerated titration design. Methods The starting 10-mg/m2 dose was followed by an initial accelerated stage (weekly dosing; n = 11). Based on liver function test (LFT) results, a 14-day, 20-mg/m2 dose lead-in period was implemented (weekly dosing with lead-in; n = 6). Results Abnormal LFT changes and gastrointestinal effects were the most common treatment-related adverse events (AEs). DLTs with 56-mg/m2 weekly dosing occurred in 1/5 patients; five patients had grade ≥ 2 abnormal LFT changes at 40- and 56-mg/m2 weekly doses. Further dose escalation ceased because of the possibility of severe abnormal LFT changes occurring. DLTs with weekly dosing with lead-in occurred in 1/5 patients at a 56-mg/m2 dose; MTD could not be determined because discontinuation criteria for additional enrollment at that particular dose level were met. As no further enrollment at lower doses occurred, dose escalation assessment was discontinued. Serious treatment-related AEs, AEs leading to treatment discontinuation, and DLTs were all related to abnormal LFT changes, suggesting that TAS4464 administration could affect liver function. This effect was dose-dependent but considered reversible. Complete or partial responses to TAS4464 were not observed; one patient achieved prolonged stable disease. Conclusions MTD could not be determined due to TAS4464 effects on liver function. Further evaluation of the mechanism of NEDD8-activating enzyme inhibitor-induced abnormal liver function is required. Trial registration number JapicCTI-173,488 (registered with Japan Pharmaceutical Information Center). Registration date 13 January 2017

scholarly journals Surufatinib Plus Toripalimab in Patients with Advanced Solid Tumors: A Single-Arm, Open-Label, Phase 1 Trial

2020 ◽  
Author(s):  
Yanshuo Cao ◽  
Ming Lu ◽  
Yu Sun ◽  
Jifang Gong ◽  
Jie Li ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Solid Tumors ◽  
Dose Escalation ◽  
Phase 1 ◽  
Fixed Dose ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
Phase 1 Trial ◽  
Open Label Phase ◽  
Grade 3

Abstract BackgroundPreclinical studies have supported a potential synergistic antitumor activity between surufatinib and anti-programed death ligand-1 (PD-L1). We describe here the results of a single-arm, open-label phase 1 trial to evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) in patients with advanced solid tumors treated with surufatinib combined with toripalimab, an inhibitor of PD-L1.MethodsThis is an open-label, dose escalation and expansion study in patients with solid tumors who had failed standard therapies or had no effective treatment. In the dose escalation stage, 3 cohorts of patients were treated with surufatinib, at dose levels of 200, 250, or 300 mg once daily (QD) in combination with a fixed dose of toripalimab 240 mg, every 3 weeks (Q3W), to evaluate maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Additional patients were enrolled in the dose expansion phase to further assess the efficacy, safety, and PK profile.ResultsFrom April 1, 2019 to July 10, 2020, 31 patients were screened, of which 28 patients were enrolled. One patient in the 300 mg cohort experienced dose limited toxicity (DLT), a grade 3 hyperthyroidism. The top 3 most common treatment-related adverse events of ≥ grade 3 were transaminases increased (17.9%), hypertension (14.3%) and blood bilirubin increased (10.7%). No treatment-related death or treatment discontinuation was identified. The RP2D was determined to be surufatinib 250 mg QD plus toripalimab 240 mg Q3W. Overall objective response rate was 22.2% [95% confidential interval (CI) 8.6‒42.3], and disease control rate reached 81.5% (95% CI 61.9‒93.7). ConclusionsSurufatinib plus toripalimab was well-tolerated, with no unexpected safety signals, and showed promising antitumor activity in patients with advanced solid tumors. Trial registrationclinicaltrials.gov, NCT03879057; Registered March 18, 2019, https://clinicaltrials.gov/ct2/show/NCT03879057

The first report of pediatric patients with solid tumors treated with venetoclax.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10524-10524
Author(s):  
Kelly C. Goldsmith ◽  
Arnauld Verschuur ◽  
Daniel A. Morgenstern ◽  
Natasha van Eijkelenburg ◽  
Sara Michele Federico ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Pediatric Patients ◽  
Wilms Tumor ◽  
Phase 1 ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Low Grade ◽  
Open Label ◽  
Therapy Regimen ◽  
Best Response

10524 Background: Dependence on the prosurvival protein B-cell lymphoma 2 (BCL-2) occurs in certain pediatric solid tumors, resulting in tumorigenesis and resistance to therapies. Venetoclax (VEN), an orally administered BCL-2-selective inhibitor, has preclinical anticancer activity in human-derived neuroblastoma models. Reported here are preliminary results from pediatric patients (pts) with recurrent or refractory (R/R) solid tumors treated with VEN monotherapy or VEN with cyclophosphamide and topotecan (Cy-Topo). Methods: This phase 1 open-label, 2-part study (NCT03236857) enrolled pts < 25 yr old with R/R malignancies; we report only on pts with solid tumors. Following a dose ramp-up, pts received 800 mg VEN (age/weight-adjusted adult equivalent) once daily for the first 8 wk; Cy-Topo was added optionally after wk 8. Dose-limiting toxicities (DLTs) were assessed during the first 21 days of VEN therapy or cycle 1 of VEN-Cy-Topo. Objectives included safety, toxicity, and preliminary efficacy. Results: As of Dec 17, 2019, 11 solid tumor pts were enrolled: neuroblastoma (n = 6), rhabdomyosarcoma (n = 2), Wilms’ tumor, Carney-Stratakis syndrome, and low-grade fibromyxoid sarcoma (n = 1 each). Median age was 11 yr (range 3–22); median time on study was 6.9 mo (range 1.2–17.8). All pts experienced ≥1 treatment-emergent adverse event (TEAE); vomiting (72%; all grades) was most common. Grade ≥3 TEAEs were reported in 82% of pts; febrile neutropenia (64%), decreased blood cell count, and neutropenia (36% each) were the most common. Seven pts received 800-mg monotherapy for 8 wk; 3 of these pts did not receive Cy-Topo after monotherapy. Of the 7 pts who received VEN-Cy-Topo, 3 pts received 400 mg VEN with Cy-Topo. DLTs of grade 4 neutropenia/thrombocytopenia with delayed count recovery occurred in 2 pts on 800 mg VEN-Cy-Topo, necessitating a dose de-escalation (to 400 mg VEN). Grade 4 neutropenia occurred in 2 pts on 400 mg VEN with Cy-Topo, leading to the addition of myeloid growth factor to the therapy regimen. The best response after 8 wk of VEN monotherapy was stable disease (SD). Six pts were evaluable for tumor response with VEN-Cy-Topo; 1 neuroblastoma pt had a complete response after 5 cycles of 400 mg VEN, 4 pts had SD (3 on 800 mg and 1 on 400 mg VEN) and 1 (800 mg VEN) had progressive disease as best response. Conclusions: Continuous dosing of VEN with Cy-Topo was not tolerated due to cytopenias in 4/7 pts with solid tumors. Discontinuous dosing of VEN with Cy-Topo is being explored. Clinical trial information: NCT03236857.

scholarly journals PC3 - 151 Toca 5: A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined with Toca FC versus Standard of Care in Patients Undergoing Planned Resection for Recurrent Glioblastoma (GBM) or Anaplastic Astrocytoma (AA) (NCT02414165)

2016 ◽  
Vol 43 (S4) ◽  
pp. S17-S17
Author(s):  
G. Zadeh ◽  
D. Bota ◽  
D. Cachia ◽  
J. Landolfi ◽  
D. Schiff ◽  
...  
Keyword(s):  
Phase 1 ◽  
Objective Response ◽  
Unmet Need ◽  
Suppressor Cells ◽  
Standard Of Care ◽  
Immune Monitoring ◽  
Recurrent Glioblastoma ◽  
Phase 2 ◽  
Open Label ◽  
Dismal Prognosis

Recurrent GBM and AA have a dismal prognosis and a high unmet need for effective therapies. Toca 511 (vocimagene amiretrorepvec) is an investigational retroviral replicating vector that encodes the transgene cytosine deaminase (CD). Toca 511 selectively infects, persists and spreads in tumor. Subsequent oral administration of 5-fluorocytosine (Toca FC) produces 5-fluorouracil (5-FU) by CD within infected cells. 5-FU kills cancer cells and myeloid derived suppressor cells, inducing robust antitumor immune responses in animal models. Clinical data from phase 1 trials are consistent with this mechanism of action, and show extended survival compared to historical controls. Toca 5 is a multicenter, randomized, open-label Phase 2/3 trial of Toca 511 and Toca FC versus standard of care administered to patients undergoing resection for first or second recurrence of GBM or AA. Phase 2 will enroll 170 patients. Primary endpoint is overall survival (OS). Key secondary endpoints are safety, objective response rate, clinical benefit rate, progression-free survival, and landmark OS. Key inclusion criteria are age 18-75 years, histologically proven GBM or AA, measurable disease preoperatively of less than 5cm, candidate for equal or greater 80% resection of enhancing tumor based on pre-operative evaluation, and KPS equal or greater to 70. Assays for immune monitoring will be performed and molecular profiling of resected tumor samples will be correlated efficacy.

scholarly journals An open-label phase 1 trial of lenvatinib plus pembrolizumab in patients with advanced selected solid tumors

2018 ◽  
Vol 29 ◽  
pp. vii81
Author(s):  
Shigehisa Kitano ◽  
Yutaka Fujiwara ◽  
Toshio Shimizu ◽  
Satoru Iwasa ◽  
Kan Yonemori ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase 1 ◽  
Open Label ◽  
Phase 1 Trial ◽  
Open Label Phase

scholarly journals An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors

2012 ◽  
Vol 69 (6) ◽  
pp. 1477-1486 ◽  
Author(s):  
Hajime Asahina ◽  
Yosuke Tamura ◽  
Hiroshi Nokihara ◽  
Noboru Yamamoto ◽  
Yoshitaka Seki ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase 1 ◽  
Japanese Patients ◽  
Open Label ◽  
Phase 1 Study ◽  
Open Label Phase

scholarly journals 506 IGNYTE: an open-label, multicenter, phase 1/2 (Ph 1/2) clinical trial of RP1 ± nivolumab in patients with advanced solid tumors

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A538-A538
Author(s):  
Mark Middleton ◽  
Mohammed Milhem ◽  
Francesca Aroldi ◽  
Joseph Sacco ◽  
Ari VanderWalde ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Response Rate ◽  
Phase 1 ◽  
Survival Rates ◽  
Complete Response ◽  
List Type ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
The Uk ◽  
Simplex Virus

BackgroundRP1 is an enhanced potency oncolytic HSV-1 which expresses a fusogenic glycoprotein (GALV-GP R-) and granulocyte macrophage colony stimulating factor (GM-CSF).1 In pre-clinical studies, RP1 demonstrated potent GALV-GP R-enhanced anti-tumor activity and immunogenic cell death. This Phase 1/2 (Ph 1/2) study was designed to evaluate the safety and efficacy of RP1 ± nivolumab (nivo) in patients (pts) with advanced solid tumors, including pts whose disease failed prior anti-PD-1/PD-L1 therapy and has reported promising interim data in a number of tumor types including cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma to date.2MethodsThis is a multi-center, first-in-human, open label, multi-cohort, non-randomized Ph1 study of RP1 alone and combined with nivo followed by Ph2 in combination with nivo in pts with recurrent advanced solid tumors including those that progressed after prior anti-PD-1/PD-L1 therapy. The Ph 1 monotherapy dose escalation (n=14) and RP-1 combination expansion (n=22) cohorts are fully enrolled. Approximately 260 pts are expected to be enrolled in the ongoing Ph 2 portion across five cohorts; melanoma (n=30, enrollment complete), non-melanoma skin cancer (n=45, to include 15 pts with anti-PD-1/PD-L1 failed disease), anti-PD-1 failed MSI-H/dMMR tumors (n=30), anti-PD-1/PD-L1-failed non-small-cell lung cancer (n=30) and a registration-directed cohort in anti-PD-1 failed cutaneous melanoma (n=125). Pts in the Ph 2 portion receive up to 10 mL of RP1 intratumorally into one or more superficial or deep seated/visceral lesions at the recommended Ph 2 dose (1x10^6 PFU/mL × 1 followed by 1x10^7 PFU/mL × 7, Q2W). Following the first dose of RP1, nivo (240 mg IV Q2W for 4 months then 480 mg IV Q4W for up to 2 years) is subsequently administered in combination. Pts may receive up to 8 additional doses of RP1 if they meet protocol-specified criteria. Tumor assessments are performed Q8W. The primary objectives of the Ph 2 part of the study are to assess the safety, tolerability, and overall response rate (ORR) of RP1 in combination with nivo, by independent review for the anti-PD1 failed melanoma cohort. Secondary objectives include duration of response, complete response rate, disease control rate, PFS, 1-year and 2-year survival rates. Exploratory objectives include biodistribution and shedding analysis of RP1 and biomarker studies, including analyses of tumor biopsies and blood samples. Enrollment is currently ongoing in the UK and US, with additional sites in the EU (including France and Spain) are expected to open in 2021.Trial RegistrationNCT03767348ReferencesThomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer 2019;7(1):214.Coffin R, Astley-Sparke P, and Middleton M (2021, June 3rd). Retrieved from https://ir.replimune.com/static-files/f4fe3349-e082-4d41-94a1-106ce7e78a23Ethics ApprovalThe study was approved by institutional review board or the local ethics committee at each site. Informed consent was obtained from patients prior to enrollment.

A phase 1/2 study of intratumoral INT230-6 alone (IT-01) or in combination with pembrolizumab [KEYNOTE-A10] in adult subjects with locally advanced, unresectable and metastatic solid tumors refractory to therapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2592-2592
Author(s):  
Anthony B. El-Khoueiry ◽  
Jacob Stephen Thomas ◽  
Anthony J. Olszanski ◽  
Nilofer Saba Azad ◽  
Giles Francis Whalen ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Tumor Regression ◽  
Phase 1 ◽  
Locally Advanced ◽  
Tumor Burden ◽  
Exploratory Analysis ◽  
Open Label ◽  
Open Label Phase ◽  
Grade 3 ◽  
Metastatic Sites

2592 Background: Study IT-01 (KEYNOTE-A10) evaluates INT230-6, a novel formulation of cisplatin (CIS) and vinblastine (VIN) with an amphiphilic cell penetration enhancer designed for intratumoral (IT) administration, alone or in combination with pembrolizumab (PEM), an antibody to PD-1. INT230-6 dosing is set by a tumor’s volume. In preclinical studies, INT230-6 increases drug dispersion throughout the tumor, allows drug diffusion into cancer cells and recruits dendritic, CD4 and CD8 T cells. The addition of PEM has been shown to improve these responses in models. Phase 1 data indicated INT230-6 alone induced tumor regression in both injected and non-injected lesions. Considering the large volume of drug injected and retained in the tumor, coupled with immune infiltration on biopsies, RECIST response methodology may not capture the benefit of INT230-6 treatment. Methods: IT-01 is an open-label phase 1/2 study, currently enrolling adult subjects with solid tumors in phase 2. INT230-6 was administered IT Q2W for 5 doses alone or with PEM 200mg Q3W. The study seeks to assess the safety and efficacy of IT INT230-6 alone and in combination with PEM. Results: 67 subjects have been enrolled (58 mono and 12 INT230-6 + PEM (3 started in mono, then received combo)) having a median of 3 prior therapies (0, 10). Median age was 60 (42, 85). 20+ cancer types were accrued; breast cancer and sarcoma were the most frequent. Over 500 image guided INT230-6 IT injections were given (253 to deep tumors) at doses of 0.3 to 172mL (86 mg CIS, 17.2 mg VIN) in a single session, which are higher amounts than typical IV doses. PK shows that 95% of INT230-6 active agents remain in the tumor. The most common (> 20%) related TEAEs for INT230-6 alone were localized pain (57%), nausea (36%), fatigue (29%) and vomiting (24%); with grade 3 TEAEs (> 1) of localized pain (5%) and anemia (3%). The safety in the combination was similar. There were no related grade 4 or 5 TEAEs. In evaluable monotherapy subjects (n = 43), the disease control rate (DCR) was 65% vs. 100% in PEM subjects (n = 5). Given the range of dose and entering tumor burden, an exploratory analysis of dose relative to tumor burden (TB) showed that subjects receiving a dose of INT230-6 < 50% of their reported TB (n = 30) had a mOS of 3.5 months. While in subjects receiving a dose of INT230-6 to ≥50% of TB (n = 37), mOS has not yet been reached after a median follow up of 9.5 months (HR: 0.26 (0.13,0.51)). Conclusions: INT230-6 is well tolerated when administered IT as monotherapy and combined with PEM. Given the challenge in assessing overall response rate following IT delivery, an exploratory analysis suggests prolonged survival for subjects receiving an INT230-6 dose ≥50% of their tumor burden compares favorably to the < 50% group and to literature accounting for prognostic factors (ECOG, LDH, # of metastatic sites). Clinical trial information: 03058289.

CDX3379-04: Phase II evaluation of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6025-6025 ◽  
Author(s):  
Julie E. Bauman ◽  
Nabil F. Saba ◽  
Trisha Michel Wise-Draper ◽  
Douglas Adkins ◽  
Paul E. O'Brien ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Phase 1 ◽  
Objective Response ◽  
Complete Response ◽  
Open Label ◽  
Stage Design ◽  
Inactive Form ◽  
Open Label Phase ◽  
Heavily Pretreated ◽  
Stage 1

6025 Background: CDX-3379, an anti-ErbB3 monoclonal antibody with a half-life-extending YTE modification in its Fc region, binds a unique epitope that locks ErbB3 in an inactive form and inhibits ErbB3 signaling, the latter implicated in tumor growth/resistance to anticancer therapies. CDX-3379 enhances antitumor activity of targeted therapies in preclinical models. In a Phase 1 clinical study, CDX-3379 was well-tolerated alone and in combination with cetuximab. A durable complete response (CR) to CDX-3379 + cetuximab was observed (8.3 months) in a patient (pt) with cetuximab-refractory HNSCC (Falchook ASCO 2016). Methods: This open-label phase 2 study (NCT03254927) was designed to enroll up to 30 pts with advanced, HPV-, HNSCC, previously treated with cisplatin, anti-PD-1 antibodies, and cetuximab-resistant (progression within 6 months), according to a Simon’s 2-stage design (13 evaluable pts in Stage 1 with ≥1 objective response allows enrollment of 14 more pts in 2nd stage). Pts receive CDX-3379 (initial dose 12 mg/kg IV every 21 days) + cetuximab (loading dose 400 mg/m2; 250 mg/m2 IV weekly) until disease progression/toxicity. Endpoints include objective response rate (primary), progression-free and overall survival, safety, pharmacokinetics, immunogenicity, and exploratory biomarkers. Results: Stage 1 accrual is complete with 14 evaluable pts treated. All pts were heavily pretreated; prior therapies included surgery (10/14) and chemotherapy (13/14). All pts had prior radiation, cetuximab and PD-1 targeted therapy. One confirmed ongoing CR (8.1+ months) was observed. 7/14 pts experienced stable disease (SD), including 4 with tumor shrinkage (8-27.5% reduction). Three pts continue treatment. Treatment-related adverse events were generally grade 1-2 and included diarrhea (53%), hypokalemia (20%), prolonged QT interval (13%) and rash (13%). Conclusions: CDX-3379 in combination with cetuximab is well tolerated with the primary toxicity of diarrhea. Signs of antitumor activity were observed in these cetuximab-resistant HNSCC pts, including an ongoing, durable CR. Complete stage 1 results will be presented. Clinical trial information: NCT03254927.

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