- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Apr 4, 2024
P1/2, N=75, Active, not recruiting,
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / Ono Pharma, BMS, rasdegafusp alfa (CDX-1401) / Celldex
Checkpoint Immunotherapy Is Associated with Preferential Activation of Tumor-Antigen Specific CD4+ T Cells in MDS (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6050;
Background : Patients with intermediate and higher-risk MDS are generally treated with the DNA hypomethylating agents (HMAs) azacytidine and decitabine...This open-label, non-randomized single center Phase 1 study used an HLA unrestricted NY-ESO-1 vaccine (CDX-1401 (1 mg) + poly-ICLC (1.8 mg)) in combination with standard dose decitabine (20mg/m2/d x 5 days) and nivolumab (3 mg/kg every 2 weeks), 4 cycles of combination therapy were planned on study; patients deriving clinical benefit could continue treatment at the discretion of the treating physician...The observation of both numerical and functional defects of this cell population in patients with myeloid neoplasia provides a possible explanation for the disappointing efficacy of immunotherapies in this disease state. Approaches to augment the number and function of specific cDC1 populations in myeloid disease might overcome this defect and thereby enhance the efficacy of immunotherapy for patients with MDS.
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Apr 4, 2023
P1/2, N=75, Active, not recruiting,
Approaches to augment the number and function of specific cDC1 populations in myeloid disease might overcome this defect and thereby enhance the efficacy of immunotherapy for patients with MDS. Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Apr 4, 2022
P1/2, N=75, Active, not recruiting,
This study reveals in vivo effects of Flt3L on innate immune cells in the setting of vaccination, leading to an immunogenic vaccine regimen. Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 5, 2021
P1, N=8, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion, Trial completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Jul 22, 2021
P1/2, N=40, Completed,
These data advocate human CLEC9A-NY-ESO-1 Ab as an attractive strategy for specific targeting of CD141 DCs to enhance tumor immunogenicity in NY-ESO-1-expressing malignancies. Active, not recruiting --> Completed | Trial completion date: Aug 2021 --> Aug 2020
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - May 4, 2021
P1/2, N=40, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Aug 2021 --> Aug 2020 Trial completion date: Mar 2022 --> Aug 2021 | Trial primary completion date: Mar 2021 --> Aug 2020
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=75, Active, not recruiting,
Trial completion date: Mar 2022 --> Aug 2021 | Trial primary completion date: Mar 2021 --> Aug 2020 Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Dec 30, 2020
P1, N=8, Active, not recruiting,
Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022 Trial completion date: Dec 2020 --> Aug 2021
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Dec 29, 2020
P1/2, N=40, Active, not recruiting,
Trial completion date: Dec 2020 --> Aug 2021 Trial completion date: Feb 2023 --> Mar 2022 | Trial primary completion date: Feb 2022 --> Mar 2021
- |||||||||| rasdegafusp alfa (CDX-1401) / Celldex
[VIRTUAL] Human CLEC9A antibodies deliver NY-ESO-1 antigen to CD141+ dendritic cells to activate naïve and memory NY-ESO-1-specific CD8+ T cells () - Oct 14, 2020 - Abstract #SITC2020SITC_1637;
The ability of the CLEC9A-NY-ESO-1 antibody to activate NY-ESO-1 specific naïve and memory CD8+ T cells was examined and compared to a vaccine comprised of a human DEC-205-NY-ESO-1 antibody that targets all human DC...Moreover, CLEC9A-NY-ESO-1 induced priming of naïve NY-ESO-1-specific CD8+ T cells with polyclonal effector function and potent tumor killing capacity in vitro. Conclusions These data advocate human CLEC9A-NY-ESO-1 antibody as an attractive strategy for specific targeting of CD141+ DC to enhance tumour immunogenicity in NY-ESO-1-expressing malignancies.
- |||||||||| rasdegafusp alfa (CDX-1401) / Celldex
[VIRTUAL] Human CLEC9A antibodies deliver NY-ESO-1 antigen to CD141+ dendritic cells to activate naïve and memory NY-ESO-1-specific CD8+ T cells () - Oct 14, 2020 - Abstract #SITC2020SITC_902;
The ability of the CLEC9A-NY-ESO-1 antibody to activate NY-ESO-1 specific naïve and memory CD8+ T cells was examined and compared to a vaccine comprised of a human DEC-205-NY-ESO-1 antibody that targets all human DC...Moreover, CLEC9A-NY-ESO-1 induced priming of naïve NY-ESO-1-specific CD8+ T cells with polyclonal effector function and potent tumor killing capacity in vitro. Conclusions These data advocate human CLEC9A-NY-ESO-1 antibody as an attractive strategy for specific targeting of CD141+ DC to enhance tumour immunogenicity in NY-ESO-1-expressing malignancies.
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment closed, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Sep 21, 2020
P1/2, N=75, Active, not recruiting,
Conclusions These data advocate human CLEC9A-NY-ESO-1 antibody as an attractive strategy for specific targeting of CD141+ DC to enhance tumour immunogenicity in NY-ESO-1-expressing malignancies. Suspended --> Active, not recruiting
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment closed, Enrollment change, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - May 14, 2020
P1/2, N=40, Active, not recruiting,
Suspended --> Active, not recruiting Recruiting --> Active, not recruiting | N=62 --> 40
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Apr 22, 2020
P1/2, N=75, Suspended,
Recruiting --> Active, not recruiting | N=62 --> 40 Trial completion date: Mar 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Mar 2021
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment closed, Enrollment change, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 19, 2020
P1, N=8, Active, not recruiting,
Trial completion date: Mar 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Mar 2021 Recruiting --> Active, not recruiting | N=18 --> 8
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Oct 15, 2019
P1/2, N=62, Recruiting,
Suspended --> Active, not recruiting | N=100 --> 60 Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2020 --> Feb 2022
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Sep 30, 2019
P1, N=18, Recruiting,
Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Feb 2020 --> Feb 2022 Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Sep 2019 --> Dec 2019
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial suspension, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jun 3, 2019
P1/2, N=75, Suspended,
These data indicate that vaccination against induced NY-ESO-1 expression can produce an antigen-specific immune response in a relatively non-immunogenic myeloid cancer and highlight the potential for induced-antigen directed immunotherapy in a group of patients with limited options. Recruiting --> Suspended
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment open, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jan 15, 2019
P1/2, N=75, Recruiting,
Recruiting --> Suspended Suspended --> Recruiting
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Trial suspension, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jun 18, 2018
P1/2, N=78, Suspended,
Suspended --> Recruiting Recruiting --> Suspended
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment open, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jun 14, 2018
P1/2, N=78, Recruiting,
Recruiting --> Suspended Suspended --> Recruiting
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Mar 31, 2018
P1/2, N=62, Recruiting,
Suspended --> Recruiting Trial completion date: Jun 2019 --> Feb 2021 | Trial primary completion date: Jun 2018 --> Feb 2020
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment open, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 29, 2018
P1, N=18, Recruiting,
Trial completion date: Jun 2019 --> Feb 2021 | Trial primary completion date: Jun 2018 --> Feb 2020 Not yet recruiting --> Recruiting
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
Trial initiation date, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 3, 2018
P1, N=18, Not yet recruiting,
Not yet recruiting --> Recruiting Initiation date: Jan 2018 --> Mar 2018
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Trial completion date, Trial primary completion date, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Feb 20, 2018
P1/2, N=62, Recruiting,
Active, not recruiting --> Recruiting | N=60 --> 100 | Trial primary completion date: Apr 2016 --> Feb 2020 | Initiation date: Apr 2014 --> Apr 2014 Trial primary completion date: Feb 2018 --> Jun 2018 | Trial completion date: Feb 2019 --> Jun 2019
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, Opdivo (nivolumab) / BMS, rasdegafusp alfa (CDX-1401) / Celldex
New P1 trial, PD(L)-1 Biomarker: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) - Dec 2, 2017
P1, N=18, Not yet recruiting,
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment open, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Oct 1, 2017
P1/2, N=78, Recruiting,
Trial primary completion date: Feb 2018 --> Jun 2018 | Trial completion date: Feb 2019 --> Jun 2019 Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2018 --> Mar 2020
- |||||||||| guadecitabine (SGI-110) / Otsuka, Tecentriq (atezolizumab) / Roche, rasdegafusp alfa (CDX-1401) / Celldex
New P1/2 trial, PD(L)-1 Biomarker, IO biomarker: Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jul 2, 2017
P1/2, N=78, Not yet recruiting,
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Hiltonol (poly-ICLC) / Oncovir, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment change, Trial withdrawal, Metastases: A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients (clinicaltrials.gov) - Dec 7, 2016
P1/2, N=0, Withdrawn,
Active, not recruiting --> Completed N=26 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| varlilumab (CDX 1127) / Celldex, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment closed, Enrollment change, Combination therapy, Metastases: A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma (clinicaltrials.gov) - Oct 3, 2016
P2, N=9, Active, not recruiting,
Active, not recruiting --> Completed | N=30 --> 18 Recruiting --> Active, not recruiting | N=100 --> 9
- |||||||||| Hiltonol (poly-ICLC) / Oncovir, epacadostat (INCB024360) / Incyte, rasdegafusp alfa (CDX-1401) / Celldex
Enrollment change, Combination therapy: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission (clinicaltrials.gov) - Mar 23, 2016
P1/2, N=68, Recruiting,
N=15 --> 9 | Trial primary completion date: Mar 2016 --> Sep 2015 N=98 --> 68
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