Study: NCT04432597

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PRGN-2009 (Phase I)
Description: On the phase I portion of the protocol PRGN-2009 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. The dose level given as booster will be the same dose participants will be receiving for D1, D15 and D29.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PRGN-2009 (Phase II)
Description: On the phase II portion of the protocol PRGN-2009 will be administered on just Day (D)1 and D15.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PRGN-2009 (Phase II)
Description: On the phase II portion of the protocol PRGN-2009 will be administered on just Day (D)1 and D15.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PRGN-2009 (Phase II)
Description: On the phase II portion of the protocol PRGN-2009 will be administered on just Day (D)1 and D15.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: M7824
Description: Subjects enrolled to Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: M7824
Description: Subjects enrolled to Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: M7824
Description: Subjects enrolled to Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: MRI
Description: MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: MRI
Description: MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: MRI
Description: MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: MRI
Description: MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Bone scan
Description: Bone scans and other imaging assessments may also be performed as clinically indicated.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Bone scan
Description: Bone scans and other imaging assessments may also be performed as clinically indicated.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Bone scan
Description: Bone scans and other imaging assessments may also be performed as clinically indicated.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Bone scan
Description: Bone scans and other imaging assessments may also be performed as clinically indicated.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: CT scan
Description: Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: CT scan
Description: Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: CT scan
Description: Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: CT scan
Description: Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain CT
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain CT
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain CT
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain CT
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain MRI
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain MRI
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain MRI
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Brain MRI
Description: Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy (Phase I)
Description: Where feasible, optional biopsies may be done at baseline as well as at week 9 and will likely be computed tomography (CT) guided. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy for phase I participants.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 9 (phase I participants).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy (Phase II)
Description: Where feasible, biopsies will be done at baseline as well as at week 4-5. Biopsies will be done by ear, nose and throat (ENT) under direct visualization. Where feasible at least 2 cores will be obtained. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 4-5 (phase II participants).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy (Phase II)
Description: Where feasible, biopsies will be done at baseline as well as at week 4-5. Biopsies will be done by ear, nose and throat (ENT) under direct visualization. Where feasible at least 2 cores will be obtained. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 4-5 (phase II participants).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biopsy (Phase II)
Description: Where feasible, biopsies will be done at baseline as well as at week 4-5. Biopsies will be done by ear, nose and throat (ENT) under direct visualization. Where feasible at least 2 cores will be obtained. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 4-5 (phase II participants).