Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Brief Summary: The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.


Options:
A: Inclusion Criteria:

* histological confirmed diagnosis cancer
* symptomatic malignant ascites
* EpCAM positive tumor
* EOCG 0-2
* negative pregnancy

Exclusion Criteria:

* acute or chronic infection
* exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
* previous treatment with mouse monoclonal antibodies
* known or suspected hypersensitivity to Removab or similar antibodies
* inadequate renal function
* inadequate hepatic function (AST, ALt, GTP,\< x ULN; bilirubin \<1.5xULN)
* Platelets \> 80000 cells/mm3; absolute neutrophil count (ANC) \< 1500 cells/mm3
* BMI \< 17
* Patients with reduced nutritional status
* Ileus within the last 30 days
* Brain metastases in cancer history
* Pregnant and nursing women
* history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
* inadequate respiratory function in option of investigator
B: Inclusion Criteria:

1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, stage II to IV at diagnosis, and post-initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
2. In second or third stable complete clinical remission, defined as a) stable cancer antigen (CA)-125 \< 35 U/ml (defined as CA-125 that had not doubled from the post chemotherapy nadir), b) unremarkable physical examination, and c) no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis were not considered definite evidence of disease.
3. Expected survival of at least 4 months.
4. Karnofsky performance scale ≥ 70%.
5. Laboratory values within the following limits:

   * Hemoglobin ≥ 10.0 g/dL
   * Neutrophil count ≥ 1.5 x 10\^9/L
   * Platelet count ≥ 80 x 10\^9/L
   * Serum creatinine ≤ 2.0 mg/dL
   * Serum bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
   * aspartate aminotransferase/alanine aminotransferase ≤ 2.5 x institutional ULN
6. Age ≥ 18 years.
7. ≥ 4 weeks since completion of prior cytotoxic chemotherapy.
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Clinically significant heart disease (New York Heart Association Class III or IV).
2. Serious intercurrent illness, eg, serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization.
3. Positive stool guaiac excluding hemorrhoids.
4. Known autoimmune disease (ie, rheumatoid arthritis, ulcerative colitis, etc); or immune deficiency (human immunodeficiency virus, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or receipt of immunosuppressive drugs such as systemic corticosteroids or cyclosporin, etc.
5. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
6. History of previous severe allergic reactions to vaccines or unknown allergens.
7. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
8. Lack of availability for immunological and clinical follow-up assessments.
9. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
10. Pregnancy or breast-feeding.
11. Women of childbearing potential: Refusal or inability to use effective means of contraception.
C: Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:

1. 18 years of age or older.
2. Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
3. Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
4. Have evaluable or measurable tumors.
5. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
6. Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:

1. Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
2. Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
3. Has active central nervous system tumors.
4. Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
D: Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria:

* Age \>/= 18 years;
* Properly executed written informed consent;
* History of histological and CA125 (\> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer;
* History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy;
* Complete clinical response defined as:
* Normal physical examination;
* No symptoms suggestive of persistent cancer;
* No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks;
* Negative chest x-ray (or chest CT scan) within the previous 4 weeks;
* Serum CA125 within the normal laboratory range.
* Adequate hematologic, renal and hepatic function:

  * Absolute Neutrophil Count (ANC) \>/=1.5 \* 109/l;
  * Platelets \>/= 75 \* 109/l;
  * Haemoglobin \>/= 6.2 mmol/l (\>9.9 g/dl);
  * Serum creatinine \</= 1.5 \* ULN (Upper Limit of Normal);
  * Bilirubin \</= 1.5 \* ULN; AST, ALT, AP \</= 2.5 \* ULN.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \</= 2.

Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are present:

* any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
* known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);
* known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);
* known infection with hepatitis B, or hepatitis C;
* history of recent myocardial infarction (\</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class \>/= III);
* previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy.
* concomitant use of any other investigational agent;
* any prior investigational anti-cancer vaccine or monoclonal antibody;
* known allergy to murine proteins;
* any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
* clinically significant active infection;
* concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);
* major surgery within the previous 2 weeks;
* radiotherapy within the previous 4 weeks;
* any significant toxicity from prior chemotherapy;
* unreliability or inability to follow protocol requirements;
* potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period;
* pregnancy.

Answer: C