Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Cervical Diseases

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Vaccines

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days.

After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab)

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil

1 cycle = 21 days

After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab).

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. 1 cycle = 21 days

Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days

The Vigil vaccine is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.

Vigil

Atezolizumab was prepared and administered at the FDA approved dose and schedule as described in the U.S. Package Insert (USPI). The initial dose was administered over one hour and if well tolerated, subsequent infusions may have been administered over 30 minutes.

Atezolizumab in formulation F03 (1200 mg per vial) was administered in 250 mL 0.9% NaCl IV infusion bags and infusion lines equipped with 0.2 μm in-line filters.

John Nemunaitis, MD

The clinical trial was a companion study to protocol CL-PTL-119 (A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) NCT02346747). Participants who had investigational product (Vigil) successfully made but were not eligible to enroll onto the VITAL study or previously randomized to placebo were given the opportunity to participate in this protocol. The main goal of this clinical trial was to determine the safety of combining Vigil therapy with atezolizumab.

The clinical trial was intended as a companion study to protocol CL-PTL-119 (VITAL study; NCT 02346747). Subjects who had tumor harvested at surgery and Vigil successfully manufactured, but then were ineligible for randomization onto the VITAL study or previously randomized to placebo, and also in subjects who have recurrent ovarian cancer were offered the opportunity to participate in this protocol. The trial was a multi-center, randomized, 3-part, open label study of Vigil, the checkpoint inhibitor atezolizumab and the combination of the two agents, in subjects with treatment refractory or recurrent epithelial ovarian cancer, or other gynecological cancers (i.e., cervical, uterine).

Part 1 was a safety run-in cohort and intervention (Vigil plus atezolizumab) was combined. The first 3 subjects registered in the trial were assigned to Part 1.

Part 2 was conducted after Part 1 participants completed combination therapy without dose-limiting toxicity. The purpose of Part 2 was to determine if Vigil given first then in sequence with atezolizumab would enhance immunotherapeutic anticancer activity. The overall efficacy of administration sequence was assessed.

Eligible subjects were randomized to receive two cycles of Vigil alone (n= 11) or two cycles of atezolizumab alone (n=10), followed by combination treatment with both of the agents.

Part 3 was an expansion cohort to allow subjects who completed all cycles of Part 2 to continue on atezolizumab alone, after Cycle 12. In this study, only 1 subject from Part 2 received additional treatment with atezolizumab. Pre-approval by sponsor was required by the sponsor before allowing subjects to continue treatment with atezolizumab in Part 3.

Subjects remained on treatment until disease progression or death or product toxic effect. Disease progression was determined radiographically by local investigators using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Part 1, radiological assessment of tumor response was performed at baseline and every third cycle thereafter. Tumor biopsy for correlative studies including scoring of tumor infiltrating lymphocyte (TIL) and PD-1 / PD-L1 expression analysis was obtained at tissue procurement and at any time after the end of cycle 3. Whole blood for correlative studies (immune function) was obtained at baseline, prior to study agent administration at the start of cycle 3 and every third cycle thereafter.

Part 2, radiological assessment of tumor response was performed at baseline, at the end of cycle 2 of single agent therapy, and every third cycle thereafter. Tumor biopsy for correlative studies including scoring of tumor infiltrating lymphocyte (TIL) and PD-1 / PD-L1 expression analysis was obtained at tissue procurement, prior to the start of combination therapy and at any time after the end of cycle 3. Whole blood for correlative studies (immune function) was obtained at baseline, prior to study agent administration at the start of cycle 3 (the first cycle of combination therapy) and every third cycle thereafter.

Part 3 schedule of assessments continued from Part 2 in which the following was assessed every third cycle: radiological assessments, tumor biopsy (if available), and whole blood collection for correlative studies.

The safety evaluation included recording of AEs and SAEs, and changes from baseline in laboratory evaluations, vital signs, electrocardiograms, and physical examinations.

Treatment was administered on an outpatient basis. A study cycle is defined as 21 days (3 weeks). Treatment was allowed to continue unless documented disease progression, discontinuation for toxicity, withdrawal of consent, or meeting other criteria for withdrawal from study. After progression, participants were contacted annually for three years for documentation of survival status information.

This was a 3 part study. Parts 1 and 3 did not involve randomization. In part 2, eligible participants were randomized to receive two cycles of either Vigil alone or Atezolizumab alone, then followed by combination treatment with the two agents.

A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers

A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)

The safety evaluation included Adverse Events (AEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs) and changes from baseline in laboratory evaluations, vital signs, electrocardiograms and physical examinations. AEs were graded according to the National Cancer Institute (NCI) CTCAE v4.03 and coded using the Medical Dictionary for Regulatory Activities. Laboratory abnormalities were graded according to the NCI CTCAE v4.03, if applicable.

Whole blood for correlative studies will be obtained at baseline, at the start of cycle 3 (the first cycle of combination therapy), every 3 cycles thereafter and end of treatment.

Overall assessment of time to progression and survival will be measured by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

In Part 1, disease progression was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter.

Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by investigators using RECIST 1.1.

In Part 1, ORR was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter.

95% confidence interval from exact binomial distribution (Blopper-Pearson method).

OS is defined as time of randomization to date of death due to any cause.

Roche-Genentech

Gradalis, Inc.

This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.

Part 1: Vigil + Atezo

Part 2 participants randomized to Vigil first received Vigil immunotherapy at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection for the first two cycles.

1 cycle = 21 days

Part 2: Vigil

Part 2 participants randomized to atezolizumab first received atezolizumab at a dose of 1200 mg as an intravenous infusion for the first two cycles. 1 cycle = 21 days

Part 2: Atezo

After Part 2 participants completed the first two cycles of Vigil or atezolizumab, then Vigil and atezolizumab was given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days

Part 2: Vigil and Atezo

Participants continue on single agent atezolizumab until disease progression. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion. 1 cycle = 21 days.

Part 3: Atezo

After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab.

1 cycle = 21 days

Part 2: Vigil Then Vigil + Atezo

After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days

Part 2: Atezo Then Vigil + Atezo

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The number of prior lines of systemic therapies was obtained from medical records during the pre-study period. Systemic therapies refers to any type of cancer treatment that targets the entire body.

Number of Prior Lines of Systemic Therapies

Eastern Cooperative Oncology Group (ECOG) Performance Status Scale is a standard way of to assess how a patient with cancer is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. ECOG scores range from 0 to 5. A lower score means the patient is better able to carry out daily activities. The assessment is made during the clinical study visit.

Baseline ECOG

Number of subjects randomized with recurrent ovarian cancer or failed to meet eligibility criteria of CL-PTL-119. There was no separate analysis for Part 3 as the one subject's data was included in Part 2 analysis.

Clinical and Regulatory Operations

Grade 4 Atezolizumab-Related

Grade 4 Vigil-Related

Grade 3 Atezolizumab-Related

Grade 3 Vigil-Related

This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab.

1 cycle = 21 days.

Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if Vigil given first then combined with atezolizumab would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab.

1 cycle = 21 days

Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if atezolizumab given first then combined with Vigil would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days

Grade 3/4 treatment-related events from first dose up to 30 days after last treatment.

Number of Treatment-emergent AEs of Vigil + Atezolizumab

After Part 1 participants completed combination therapy without dose-limiting toxicity, Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab.

1 cycle = 21 days

After Part 1 participants completed combination therapy without dose-limiting toxicity, Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days

Samples were not analyzed for immune response data.

Immune Response Rate

Part 1 is a safety run-in cohort. Vigil immunotherapy will be administered at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab will be administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. The initial dose is to be administered over one hour and if well tolerated, subsequent infusions may be administered over 30 minutes. Vigil should be administered first, followed 30 minutes later by atezolizumab.

Vigil: Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).

Atezolizumab: Atezolizumab is provided in a single-use, 20-cc USP/Ph. Eur. Type 1 glass vial as a colorless to slightly-yellow, sterile, preservative-free clear liquid solution intended for IV administration. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. The atezolizumab drug product is formulated as 60 mg/mL atezolizumab in 20 mM histidine acetate, 120 mM sucrose, 0.04% polysorbate 20, pH 5.8.

Part 2 is a randomized, open label study of Vigil, the checkpoint inhibitor Atezolizumab and the combination of the two agents.

Vigil immunotherapy will be administered at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses for 2 cycles (1 cycle = 21 days).

Vigil: Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).

Atezolizumab: Atezolizumab is provided in a single-use, 20-cc USP/Ph. Eur. Type 1 glass vial as a colorless to slightly-yellow, sterile, preservative-free clear liquid solution intended for IV administration. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. The atezolizumab drug product is formulated as 60 mg/mL atezolizumab in 20 mM histidine acetate, 120 mM sucrose, 0.04% polysorbate 20, pH 5.8 (Phase III formulation).

Part 2 is a randomized, open label study of Vigil, the checkpoint inhibitor Atezolizumab and the combination of the two agents

Atezolizumab will be administered at a dose of 1200 mg as an intravenous infusion every 3 weeks for 2 cycles (1 cycle = 21 days). The initial dose is to be administered over one hour and if well tolerated, subsequent infusions may be administered over 30 minutes.

Vigil: Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).

Atezolizumab: Atezolizumab is provided in a single-use, 20-cc USP/Ph. Eur. Type 1 glass vial as a colorless to slightly-yellow, sterile, preservative-free clear liquid solution intended for IV administration. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. The atezolizumab drug product is formulated as 60 mg/mL atezolizumab in 20 mM histidine acetate, 120 mM sucrose, 0.04% polysorbate 20, pH 5.8 (Phase III formulation).

Time to Progression

This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days

Radiographic Overall Response Rate (ORR)

Overall Survival (OS)

After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab.

Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks.

1 cycle = 21 days

After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence.

Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab.

Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks.

1 cycle = 21 days

Overall Study

Skin and Connective Tissue Diseases

Sarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Immunologic Factors

Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).

This is an expanded access study involving an investigational product named Vigil. Vigil is considered immunotherapy. Patients who participated in another clinical trial sponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standard operation, however failed the criteria to enroll in the other clinical trial to receive Vigil are eligible to screen for this expanded access trial to receive the Vigil made from their cancer cells.

In this study, eligible participants will receive intradermal (under the skin) injections of Vigil, once every 4 weeks (28 days) for 1-12 doses, depending on the number of doses that was made from the cancer cells and if the participant is clinically stable. During the treatment portion of the study, in addition to receiving Vigil injections, participants will also have a physical exam, blood collection for routine and research tests, and assessment of medications, adverse events, and performance status information will be collected. Radiological tumor assessments will be performed every 3 months from Cycle 1. Once treatment ends, participants will continue to be seen in the clinic every 3 months for similar assessments until disease progression occurs. After disease progression, participants will be contacted by phone 4 times a year to determine post study treatment and survival status information.

This is an Expanded Access trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors. Approximately 40 subjects who had tissue procured and Vigil manufactured but fail manufacturing release criteria under a previous Gradalis protocol are considered for this study.

Eligible participants will receive a minimum of 1 and a maximum of 12 doses of Vigil intradermal injections every 4 weeks as monotherapy. Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses in response to autologous tumor antigens will be collected at screening, Day 1 (prior to Vigil administration) at Cycles 2, 4, and 6, end of treatment (EOT); 3 months after EOT, and every 6 months thereafter for those in response follow up. For subjects with Ewing's sarcoma, blood for ctDNA analysis will be collected at screening, on Day 1 prior to Vigil administration at Cycles 2, 3, 4, and 6, and EOT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers	NCT03073525	Advanced Gyneco... Ovarian Cancer Cervical Cancer Uterine Cancer	Vigil Atezolizumab	18 Years -	Gradalis, Inc.
A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers	NCT03073525	Advanced Gyneco... Ovarian Cancer Cervical Cancer Uterine Cancer	Vigil Atezolizumab	18 Years -	Gradalis, Inc.
Expanded Access of Vigil in Solid Tumors	NCT03842865	Solid Tumor Ewing Sarcoma Ewing's Tumor M... Ewing's Sarcoma... Advanced Gyneco... Ovarian Cancer Cervical Cancer Uterine Cancer	Vigil	2 Years -	Gradalis, Inc.

Spots Global Cancer Trial Database for advanced gynecological cancers