Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antibodies

Immunoglobulins

AGEN2034 administered with placebo monotherapy: approximately 100 patients.

AGEN2034 administered in combination with AGEN1884 (combination therapy): approximately 100 patients.

AGEN2034

AGEN1884

Medical Director

This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate.

This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2- combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate Patients will receive AGEN2034 with placebo as a monotherapy or with AGEN1884 as combination therapy for a maximum of 24 months or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs. Placebo administration in Treatment Arm 1 (AGEN 2034 monotherapy) of the study is intended to preserve the integrity of the investigators' interpretation of the efficacy and safety data by eliminating biases in disease assessment monitoring, declaration of disease progression, and assessment of toxicities. Therefore, it is understood that investigators, patients, and research personnel will not know whether patients have received AGEN2034/placebo (Treatment Arm 1) or AGEN2034/AGEN1884 (Treatment Arm 2).

An Independent Data Monitoring Committee (IDMC) will evaluate safety and efficacy. An IRRC will be established to adjudicate tumor response.

RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer

A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (Anti-PD-1) as a Monotherapy or Combination Therapy With AGEN1884 (Anti- CTLA4) or With Placebo in Women With Recurrent Cervical Cancer (Second Line) - RaPiDS

To assess the Objective Response Rate (ORR) to the treatment of AGEN2034 (anti-PD-1) administered with placebo (Treatment Arm 1 - monotherapy), or with AGEN1884 (anti-CTLA4) (Treatment Arm 2 - combination therapy), defined as the binomial proportion of intent to treat (ITT) patients with best overall response (BOR) of complete response (CR) or partial response (PR), in women with recurrent/persistent/metastatic cervical cancer who have progressed following first-line therapy. BOR will be determined by the Independent Radiology Review Committee (IRRC), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

To confirm the safety and tolerability of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy) in patients with recurrent, progressive second-line cervical cancer.

To assess duration of response (DOR), stable disease (SD), duration of stable disease and disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) per RECIST 1.1 for AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy).

To estimate the time to confirmed progression by the investigator per iRECIST for AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy).

To evaluate the immunogenicity of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy) and to correlate it to exposure and biological activity.

To characterize AGEN2034 and AGEN1884 pharmacokinetics (PK).

To assess quality of life in the treated population using the Functional Assessment of Cancer Therapy - Cervical Cancer Trial Outcome Index (FACT-Cx)

To assess quality of life in the treated population using Brief Pain Inventory (BPI)

GOG Foundation

Agenus Inc.

Antibodies, Monoclonal

This is an open-label, Phase 1/2, multicenter study to evaluate the safety, PK, and PD of an anti-CTLA-4 human monoclonal antibody (AGEN1884) in subjects with advanced or refractory cancer and in subjects who have progressed during treatment with a PD-1/PD-L1 inhibitor as their most recent therapy.

The phase 1 portion of the study has been completed; It enrolled adult subjects with refractory, advanced cancer in a 3+3 dose escalation cohort.

The phase 2 portion consists of up to 60 patients who have progressed during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).

AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Subjects With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy

Phase 1/2, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884) in Subjects With Advanced or Refractory Cancer and in Subjects Who Have Progressed During Treatment With a PD 1/PD-L1 Inhibitor as Their Most Recent Therapy

Summary of changes from baseline in weight and systolic and diastolic blood pressure, frequency of abnormal and clinically significant findings in overall ECG interpretation and QT interval \> 470 msec; frequency of occurrence of grade 3 findings by CTCAE version 5 any time during the study for anemia, decreased leucocyte, platelet counts, increased creatinine, ALT, AST, or bilirubin, hypokalemia, hyperkalemia, hyponatremia, hypernatremia, proteinuria

To evaluate the preliminary efficacy of AGEN1884

An anti-programmed death 1 (PD-1) monoclonal antibody.

Balstilimab

An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

Zalifrelimab

Agenus, Inc.

This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.

This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)

Urinary Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Gemcitabine

Cisplatin

Antimetabolites

Antineoplastic Agents, Alkylating

The safety run-in of the study will first enroll three patients who will begin treatment with cisplatin and gemcitabine plus AGEN2034 and AGEN1884 as outlined in the treatment plan. These first 3 patients will be assessed for DLTs and there will be a pause in enrollment until all three complete the DLT period. If there are no DLTs in the first 3 patients, we will proceed to further accrual to stage I of phase II. If there is 1 DLT in the initial 3 patients, we will enroll 3 additional patients to the safety run-in. If \> 2 DLTs are experienced in the initial 3 patients, the study will be terminated, otherwise additional subjects will be enrolled into the phase ll first stage and reassessed after 2 cycles of therapy and proceed to planned surgery. If criteria are met to continue to the second stage of the Phase II portion of the study, additional patients will be enrolled for an anticipated total of 36 evaluable patients. Patients will be treated and endpoints evaluated.

A fully human monoclonal Anti-PD-1 Antibody

Chethan Ramamurthy, MD

This is a phase II trial to evaluate the tolerability, efficacy, and immune outcomes of AGEN1884 plus AGEN2034 concurrent with cisplatin and gemcitabine in the neoadjuvant treatment of muscle-invasive, non-metastatic bladder cancer prior to radical cystectomy.

We will begin with an initial safety run-in to establish the safety of the combination prior to expansion to the full planned phase II. The overall phase II will be an open-label, single arm study in two stages to evaluate the efficacy of the combination in pathologic downstaging of MIBC. Patients will receive four 21-day cycles of neoadjuvant therapy consisting of cisplatin and gemcitabine plus AGEN2034 in all 4 cycles and AGEN1884 in cycles 1 and 3. Patients will proceed to radical cystectomy within 10 weeks after the final dose of this therapy. The primary endpoint of pathologic tumor downstaging will be assessed at the time of cystectomy.

This is a phase II trial to evaluate the tolerability, efficacy, and immune outcomes of AGEN1884 plus AGEN2034 concurrent with cisplatin and gemcitabine in the neoadjuvant treatment of muscle-invasive, non-metastatic bladder cancer prior to radical cystectomy. We will begin with an initial safety run-in to establish the safety of the combination prior to expansion to the full planned phase II. The overall phase II will be an open-label, single arm study in two stages to evaluate the efficacy of the combination in pathologic downstaging of MIBC.

AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer

A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy

To correlate clinical outcomes with immune and biologic endpoints and identify patient and tumor characteristics that can predict treatment responses

pT0 or pCR (defined as no residual tumor in bladder and lymph nodes on resected specimen). Surgery should be performed within 6 weeks after completing up to 4 cycles (last dose) of neoadjuvant therapy, but can be done up to 10 weeks after treatment ends to be evaluable. Otherwise this patient must be replaced for response evaluation.

Evaluation of safety and tolerability of using Agen1884 plus AGEN2034 plus cisplating and gemcitabine chemotherapy in the neoadjuvant treatment of muscle-invasive bladder cancer prior to radial cystectomy. Number of adverse events assessed between 3-5 using the National Cancer Institution Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

Number of subjects who achieved downstaging of the tumor at completion of the possible 4 chemotherapy cycles.

Number of subjects that progressed from therapy to surgery

Number of subjects that survived to 1 year from study start without disease progression

The University of Texas Health Science Center at San Antonio

Treatment with the following drugs:

AGEN1884: A fully human monoclonal Anti-PD-1 Antibody

AGEN2034: A fully human monoclonal Anti-PD-1 Antibody

Cisplatin: Alkylating antineoplastic agent

Gemcitabine: Antimetabolite antineoplastic agent

Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies

Participants enrolled with muscle-invasive bladder cancer.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Robert Svatek, MD

Pathologic Tumor Downstaging of >T2 to pT0

Evaluation of Safety and Tolerability of AGEN1884 Plus AGEN2034 Plus Cisplatin and Gemcitabine

Pathologic Downstaging to <T2 Rate

Completion of Surgery

Due to early termination of the study, data were not collected for this outcome measure

Progression-free Survival at 1 Year

Due to early termination, not data were collected for this outcome

Correlate Immune Outcomes

Patients will be treated and endpoints evaluated:

AGEN1884: A fully human monoclonal Anti-PD-1 Antibody AGEN2034: A fully human monoclonal Anti-PD-1 Antibody Cisplatin: Alkylating antineoplastic agent Gemcitabine: Antimetabolite antineoplastic agent

Safety Run in Phase

Phase II, Stage 1

Phase ll, Stage 2

Rare Diseases

Hemangiosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

AGEN2034 - dose of 3 mg/kg IV every 2 weeks for up to 24 months

AGEN2034 - dose of 3 mg/kg IV every 2 weeks + AGEN1884 - dose of 1 mg/kg IV every 6 weeks (following AGEN2034 infusion), for up to 24 months

This Phase 2, open-label study is designed to examine the efficacy and safety of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 in patients with recurrent, inoperable or metastatic Angiosarcoma (AS).

This Phase 2, open-label study is designed to examine the efficacy and safety of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 in patients with recurrent, inoperable or metastatic AS.

Three cohorts will be enrolled into 2 Parts of the study as follows:

Part 1

* Cohort 1: Qualifying patients that are checkpoint inhibitor naïve will be enrolled into single-agent AGEN2034
* Cohort 2: Qualifying patients that are inhibitor (PD-1/L1) resistant will be enrolled into combination AGEN2034 + AGEN1884

Part 2

• Cohort 3: Qualifying patients that are checkpoint inhibitor naïve will be enrolled into combination AGEN2034 + AGEN1884. Part 2 will begin enrollment after enrollment in Part 1 is completed

The study will be conducted in 2 parts:

In Part 1, checkpoint inhibitor naïve patients will be treated with single-agent AGEN2034 (Cohort 1) and patients resistant to PD-1/PD-L1 (defined as prior progression on PD 1/PD-L1 treatment) will be treated with combination of AGEN2034+AGEN1884 (Cohort 2). Patients from Cohort 1 who experience PD may be considered (as PD-1 resistant) for transition to Cohort 2.

In Part 2, the study will enroll checkpoint inhibitor naïve patients for treatment with combination AGEN2034+AGEN1884 (Cohort 3). Part 2 will begin enrollment after enrollment in Part 1 is completed.

All patients will receive study treatment for up to 2 years until confirmed disease progression, unacceptable toxicity, or until the patient wishes to withdraw consent for any reason. Patients will be followed for safety at 30 and 90 days, and for survival every 2 months for at least 12 months from their last dose of study treatment. Each treatment cycle will be 6 weeks.

An IRC will be established to adjudicate tumor response based on imaging studies, photography, and clinical response. The primary endpoints will be based on the IRC assessment of response per RECIST v1.1.

AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma

A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination With AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma

To evaluate the response rate of single-agent AGEN2034 and combination AGEN2034 + AGEN1884 per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in patients with recurrent angiosarcoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer	NCT03894215	Cervical Cancer	AGEN2034 AGEN1884	18 Years -	Agenus Inc.
AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Subjects With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy	NCT02694822	Advanced Solid ... Advanced Solid ...	AGEN1884	18 Years -	Agenus Inc.
AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Subjects With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy	NCT02694822	Advanced Solid ... Advanced Solid ...	AGEN1884	18 Years -	Agenus Inc.
Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)	NCT05572970	Cancer	Balstilimab Zalifrelimab	18 Years -	Agenus Inc.
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer	NCT04430036	Urinary Bladder...	AGEN1884 AGEN2034 Cisplatin Gemcitabine	18 Years -	The University of Texas Health Science Center at San Antonio
AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma	NCT04607200	Angiosarcoma	AGEN2034 AGEN1884	18 Years -	Agenus Inc.

Spots Global Cancer Trial Database for agen1884

Every month we try and update this database with for agen1884 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for agen1884

Every month we try and update this database with for agen1884 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for agen1884 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.