Write Phase II clinical trial protocol for new cancer immunotherapy. Help me: 1) Design study (randomized, double-blind, placebo-controlled), 2) Define eligibility criteria and recruitment strategy, 3) Detail intervention and control conditions, 4) Specify primary and secondary outcomes with measures, 5) Plan statistical analysis (sample size, interim analyses), 6) Address safety monitoring and adverse events, 7) Write informed consent document

Prompt
Write Phase II clinical trial protocol for new cancer immunotherapy. Help me: 1) Design study (randomized, double-blind, placebo-controlled), 2) Define eligibility criteria and recruitment strategy, 3) Detail intervention and control conditions, 4) Specify primary and secondary outcomes with measures, 5) Plan statistical analysis (sample size, interim analyses), 6) Address safety monitoring and adverse events, 7) Write informed consent document
ClaudeAnthropic
Write Phase II clinical trial protocol for new cancer immunotherapy. Help me: 1) Design study (randomized, double-blind, placebo-controlled), 2) Define eligibility criteria and recruitment strategy, 3) Detail intervention and control conditions, 4) Specify primary and secondary outcomes with measures, 5) Plan statistical analysis (sample size, interim analyses), 6) Address safety monitoring and adverse events, 7) Write informed consent document

Phase II Clinical Trial Protocol: Novel Cancer Immunotherapy

PROTOCOL SUMMARY

Protocol Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of IMM-2024 in Combination with Standard Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Protocol Number: IMM-2024-P2-001
Version: 1.0
Date: [Current Date]
Sponsor: [Institution/Company Name]
Principal Investigator: [Name, Credentials]

1. STUDY DESIGN

1.1 Study Overview


This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial evaluating the efficacy and safety of IMM-2024, a novel immune checkpoint inhibitor targeting the TIGIT pathway, in combination with standard platinum-based chemotherapy versus placebo plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC).

1.2 Study Schema

Screening (28 days)
         ↓
Randomization (1:1)
         ↓
    ┌────┴────┐
    ↓         ↓
Arm A         Arm B
IMM-2024 +    Placebo +
Chemo         Chemo
    ↓         ↓
Treatment Period (up to 24 months or until disease progression)
         ↓
Follow-up Period (survival monitoring every 3 months)

1.3 Study Duration


  • Enrollment Period: 18-24 months

  • Treatment Period: Up to 24 months per patient

  • Follow-up Period: Until death, withdrawal of consent, or study closure

  • Total Study Duration: Approximately 48 months


1.4 Randomization and Blinding

Randomization:

  • 1:1 randomization stratified by:

  • PD-L1 expression (<1%, 1-49%, ≥50%)

  • Disease stage (IIIB/IIIC vs IV)

  • Smoking history (current/former vs never)

  • ECOG performance status (0-1 vs 2)


Blinding:
  • Double-blind design maintained throughout treatment period

  • IMM-2024 and placebo prepared identically in appearance

  • Independent Data Monitoring Committee (DMC) has access to unblinded data

  • Unblinding permitted only for serious safety concerns per protocol


2. ELIGIBILITY CRITERIA AND RECRUITMENT STRATEGY

2.1 Inclusion Criteria


  • Age: ≥18 years at time of consent

  • Diagnosis: Histologically or cytologically confirmed advanced (Stage IIIB/IIIC not amenable to curative therapy or Stage IV) NSCLC

  • Treatment Status: No prior systemic therapy for advanced disease (prior adjuvant/neoadjuvant therapy allowed if completed >12 months prior)

  • Tumor Biology:

  • Non-squamous or squamous histology

  • Known PD-L1 expression status

  • Absence of targetable EGFR mutations or ALK rearrangements (for non-squamous)

  • Measurable Disease: At least one measurable lesion per RECIST v1.1

  • Performance Status: ECOG 0-2

  • Life Expectancy: ≥3 months

  • Adequate Organ Function:

  • Absolute neutrophil count ≥1,500/μL

  • Platelets ≥100,000/μL

  • Hemoglobin ≥9.0 g/dL

  • Serum creatinine ≤1.5× ULN or CrCl ≥60 mL/min

  • Total bilirubin ≤1.5× ULN (≤3× ULN if Gilbert's syndrome)

  • AST/ALT ≤3× ULN (≤5× ULN if liver metastases)

  • Contraception: Agree to use effective contraception during treatment and for 6 months after last dose

  • Consent: Able to provide written informe
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GrokxAI
Write Phase II clinical trial protocol for new cancer immunotherapy. Help me: 1) Design study (randomized, double-blind, placebo-controlled), 2) Define eligibility criteria and recruitment strategy, 3) Detail intervention and control conditions, 4) Specify primary and secondary outcomes with measures, 5) Plan statistical analysis (sample size, interim analyses), 6) Address safety monitoring and adverse events, 7) Write informed consent document

Below is a comprehensive Phase II clinical trial protocol for a hypothetical new cancer immunotherapy called "NeoVax-T," a tumor-specific vaccine designed to elicit T-cell responses against neoantigens in patients with advanced melanoma. This protocol is structured to address your specific requests (1–7). It is fictional and for illustrative purposes only—not for actual use without regulatory approval (e.g., from FDA or EMA) and ethical review (e.g., IRB). In a real scenario, consult experts, legal advisors, and regulatory bodies.

Phase II Clinical Trial Protocol: NeoVax-T Immunotherapy for Advanced Melanoma

1. Study Design


This is a multicenter, randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of NeoVax-T in patients with unresectable stage III or IV melanoma who have progressed on or are intolerant to standard therapies (e.g., PD-1 inhibitors like pembrolizumab).
  • Randomization: Patients will be randomized 1:1 to the intervention or control arm using stratified block randomization to balance key prognostic factors (e.g., BRAF mutation status, baseline LDH levels, and prior PD-1 therapy response). Randomization will be performed centrally via an interactive web-response system (IWRS) to ensure allocation concealment.

  • Blinding: Double-blind design where patients, investigators, and outcome assessors are blinded to treatment assignment. Unblinding will occur only for safety reasons or at study end.

  • Duration: Treatment phase up to 24 months or disease progression; follow-up for overall survival up to 5 years.

  • Sample Size: 200 patients total (100 per arm) across 10–15 sites in the US and Europe.

  • Objectives: Primary: Assess clinical efficacy. Secondary: Evaluate immunological responses, safety, and quality of life. Exploratory: Biomarker correlates of response.

  • Study Timeline: Recruitment: 18 months; Treatment/Follow-up: 3–5 years.


2. Eligibility Criteria and Recruitment Strategy


Eligibility Criteria


Inclusion Criteria


  • Adults (≥18 years) with histologically confirmed unresectable stage III or IV cutaneous melanoma.

  • Measurable disease per RECIST v1.1 (at least one target lesion ≥1 cm).

  • ECOG performance status 0–1.

  • Progression or intolerance to ≥1 prior line of systemic therapy (e.g., anti-PD-1/PD-L1 therapy; prior anti-CTLA-4 allowed if ≥6 months since last dose).

  • Adequate organ function: ANC ≥1,500/μL, platelets ≥100,000/μL, hemoglobin ≥9 g/dL; creatinine ≤1.5x ULN; AST/ALT ≤2.5x ULN; bilirubin ≤1.5x ULN.

  • Willingness to undergo tumor biopsy for neoantigen identification.

  • Life expectancy ≥12 weeks.

  • Negative pregnancy test for women of childbearing potential; use of effective contraception for both sexes during treatment and 6 months post-treatment.


Exclusion Criteria


  • Known brain metastases (unless stable and treated ≥4 weeks prior, with no steroids in last 2 weeks).

  • Active autoimmune disease requiring systemic immunosuppression.

  • Prior allogeneic stem cell transplant or gene therapy.

  • Active infection requiring IV antibiotics.

  • HIV, hepatitis B/C, or other uncontrolled infection.

  • Any condition impairing consent or compliance.


Recruitment Strategy


  • Target Population: Patients from academic medical centers, community oncology networks, and melanoma referral clinics in the US (e.g., via NCI's Cancer Trials Support Unit) and Europe (e.g., EORTC network).

  • Methods:

  • Advertise via clinicaltrials.gov, oncology conferences, patient advocacy groups (e.g., Melanoma Research Alliance), and electronic health record alerts in participating sites.

  • Site selection: 10–15 high-volume centers with expertise in immunotherapy and biopsy procedures; aim for diverse representation (e.g., ≥30% racial/ethnic minorities).

  • Screening: Initial phone/email prescreening by site coordinators; in-person evaluation with tumor biopsy for neoantigen sequencing (results available within 4 weeks).

  • Enrollment Goal: 200 patients over 18 months, assuming 20% screen failure rate.

  • Retention: Monthly check-ins, travel reimbursement, and patient navigators to address barriers.


3. Intervention and Control Conditions


  • Intervention Arm (NeoVax-T): Personalized neoantigen vaccine administered as 12 intradermal injections (0.5 mL each, with adjuvant QS-21) over 6 months (weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44; boosters at 12 and 18 months if stable). Dose: 100–300 μg total peptide per injection, based on patient-specific neoantigens identified via tumor sequencing. Administered with optional concurrent low-dose cyclophosphamide (300 mg/m² orally day -1) to reduce regulatory T-cells. No concurrent anticancer therapy except supportive care.

  • Control Arm (Placebo): Matching intradermal injections of saline vehicle with adjuvant, on the same schedule, to maintain blinding. No cyclophosphamide.

  • Administration: Injections in the thigh by trained personnel; post-injection observation for 30 minutes. Compliance monitored via patient diaries and IWRS.

  • Discontinuation: At disease progression, unacceptable toxicity, patient withdrawal, or study end. Crossover to active therapy not allowed in Phase II.


4. Primary and Secondary Outcomes with Measures


Primary Outcome


  • Progression-Free Survival (PFS): Time from randomization to disease progression (per blinded independent central review using RECIST v1.1) or death from any cause. Measured via CT/MRI scans every 8 weeks for first 6 months, then every 12 weeks.


Secondary Outcomes


  • Overall Survival (OS): Time from randomization to death from any cause. Measured via vital status checks every 3 months post-treatment.

  • Objective Response Rate (ORR): Proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.

  • Immune Response: Neoantigen-specific T-cell responses measured by ELISPOT assay for IFN-γ production in peripheral blood at baseline, week 12, and week 24. Tumor-infiltrating lymphocyte (TIL) density via IHC on optional on-treatment biopsies.

  • Safety and Tolerability: Incidence/severity of adverse events (AEs) per CTCAE v5.0.

  • Quality of Life (QoL): Change from baseline in EORTC QLQ-C30 and melanoma-specific module (QLQ-MEL) scores, assessed every 12 weeks.


5. Statistical Analysis


  • Analysis Populations: Intent-to-treat (ITT) for efficacy; safety population (all treated patients) for AEs.

  • Sample Size Justification: Based on PFS as primary endpoint. Assuming 6-month PFS of 40% in intervention vs. 20% in control (HR=0.58), 90% power, 2-sided α=0.05 (log-rank test), with 20% dropout and 12-month accrual, requires 200 patients (100/arm). Powered to detect ≥15% absolute improvement in ORR.

  • Primary Analysis: Cox proportional hazards model for PFS (stratified by randomization factors); Kaplan-Meier curves with 95% CI. Interim efficacy analysis at 50% events (Futility: O'Brien-Fleming boundaries; Efficacy: α=0.025).

  • Secondary Analyses: ORR via Cochran-Mantel-Haenszel test; OS via log-rank; Immune responses via mixed-effects models. QoL via linear mixed models. Multiplicity adjusted via hierarchical testing.

  • Interim Analyses: Data Safety Monitoring Board (DSMC) reviews at 25%, 50%, and 75% of expected events for futility/efficacy (Lan-DeMets α-spending function) and safety.

  • Software: SAS v9.4 or R; missing data handled via multiple imputation if >5%.


6. Safety Monitoring and Adverse Events


  • Monitoring: All AEs/SAEs reported from informed consent through 30 days post-last dose (90 days for immune-related AEs). Ongoing via site reports to sponsor weekly; DSMC quarterly reviews.

  • Adverse Events: Graded per CTCAE v5.0. Expected AEs: Injection-site reactions (Grade 1–2), flu-like symptoms, fatigue. Immune-related AEs (irAEs, e.g., colitis, pneumonitis) monitored with labs (e.g., thyroid function every 4 weeks) and specialist referrals.

  • Dose Modifications: Delay/reduce for Grade ≥3 non-hematologic AEs or Grade ≥2 held until resolution. Permanent discontinuation for life-threatening AEs or Grade 4 irAEs.

  • Safety Oversight: Independent DSMC with authority to recommend pausing/enrollment halt. Report SAEs to IRB/DSMC within 24 hours; annual safety updates to regulators. Pregnancy reporting mandatory.

  • Stopping Rules: Interim halt if >20% Grade 3/4 irAEs attributable to treatment or excess mortality (per DSMC).


7. Informed Consent Document


Informed Consent Form (ICF) Template


Study Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of NeoVax-T Immunotherapy in Advanced Melanoma (NCTXXXXXXX).

Principal Investigator: [Name], MD, [Institution].

Introduction: You are being invited to participate in this research study because you have advanced melanoma that has not responded to standard treatments. The study tests a new personalized vaccine, NeoVax-T, which aims to train your immune system to fight cancer by targeting unique markers on your tumor cells. About 200 people will join this study at multiple sites.

**What is the Purpose

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MistralMistral AI
Write Phase II clinical trial protocol for new cancer immunotherapy. Help me: 1) Design study (randomized, double-blind, placebo-controlled), 2) Define eligibility criteria and recruitment strategy, 3) Detail intervention and control conditions, 4) Specify primary and secondary outcomes with measures, 5) Plan statistical analysis (sample size, interim analyses), 6) Address safety monitoring and adverse events, 7) Write informed consent document
Phase II Clinical Trial Protocol: New Cancer Immunotherapy (NCI)

1. Study Design

  • Study Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate the Efficacy and Safety of NCI in Patients with Advanced Solid Tumors

  • Study Design: Randomized, double-blind, placebo-controlled, parallel-group, Phase II clinical trial

  • Randomization Ratio: 2:1 (NCI : Placebo)

  • Stratification Factors: Tumor type, prior treatment lines, and study center


2. Eligibility Criteria and Recruitment Strategy

Inclusion Criteria:

  • Histologically confirmed advanced or metastatic solid tumors refractory to standard therapy

  • Age ≥ 18 years

  • ECOG performance status 0-1

  • Adequate organ function

  • Measurable disease per RECIST v1.1

  • Willing and able to provide informed consent


Exclusion Criteria:
  • Active brain metastases or leptomeningeal disease

  • Prior treatment with any T-cell redirecting therapy

  • Active autoimmune disease

  • Active infection requiring systemic therapy

  • Pregnant or breastfeeding women


Recruitment Strategy:
  • Recruitment from investigator sites' patient databases, referrals, and clinicaltrials.gov listing

  • Awareness campaigns through patient advocacy groups and social media


3. Intervention and Control Conditions
  • Intervention: NCI administered intravenously at a dose of X mg/kg every 3 weeks for up to 24 months

  • Control: Placebo administered intravenously every 3 weeks for up to 24 months

  • Both arms will receive best supportive care


4. Primary and Secondary Outcomes with Measures

Primary Outcome:

  • Objective Response Rate (ORR) assessed by RECIST v1.1


Secondary Outcomes:
  • Progression-Free Survival (PFS)

  • Overall Survival (OS)

  • Duration of Response (DOR)

  • Disease Control Rate (DCR)

  • Safety and tolerability assessed by CTCAE v5.0

  • Pharmacokinetics (PK) and Immunogenicity

  • Quality of Life (QoL) assessed by EORTC QLQ-C30


5. Statistical Analysis
  • Sample Size: Approximately 150 patients (100 NCI, 50 Placebo) to detect an improvement in ORR from 10% (Placebo) to 25% (NCI) with 80% power and a two-sided alpha of 0.05

  • Interim Analyses: One interim analysis for safety and futility will be performed after 50% of patients have been enrolled and followed for a minimum of 3 months

  • Final Analysis: The primary efficacy analysis will be performed when all patients have been followed for at least 6 months or have discontinued treatment

  • Statistical Tests: Chi-squared test for ORR and DCR comparison, Log-rank test for PFS and OS comparison, and linear mixed models for QoL analysis


6. Safety Monitoring and Adverse Events
  • Safety will be monitored continuously throughout the study by investigators and an independent Data and Safety Monitoring Board (DSMB)

  • Adverse Events (AEs) will be recorded and graded according to CTCAE v5.0

  • Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours, and the DSMB will be notified within 72 hours

  • Dose modifications and discontinuations will be performed according to pre-specified dose-limiting toxicity guidelines


7. Informed Consent Document

INFORMED CONSENT DOCUMENT

Study Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate the Efficacy and Safety of NCI in Patients with Advanced Solid Tumors

Purpose of the Study: The purpose of this study is to evaluate the efficacy and safety of NCI in patients with advanced solid tumors.

Study Procedures: If you decide to participate, you will be randomly assigned to receive either NCI or a placebo intravenously every 3 weeks for up to 24 months. Additionally, you will have regular study visits, blood tests, and imaging scans to monitor your disease and assess your response to treatment.

Potential Risks: Participation in this study may involve risks such as allergic reactions, infusion reactions, or other side effects that may be serious or life-threatening. The study doctor will discuss these risks with you in detail.

Potential Benefits: You may or may not benefit from participating in this study. However, information gained from this study may help others with advanced solid tumors in the future.

Confidentiality: Your personal information will be kept confidential, and your study data will be identified by a unique study number.

Voluntary Participation: Participation in this study is voluntary. You may refuse to participate or withdraw from the study at any time without penalty.

Contact Information: If you have any questions or concerns about the study, please contact the study doctor or study coordinator at [Phone Number] or [Email].

Signature:

\ \\\\\\\\\\\\\\\\\\\\\\ Date: \\\/\\\/\\\
Participant's Name (Printed)

\ \\\\\\\\\\\\\\\\\\\\\\ Date: \\\/\\\/\\\
Participant's Signature

\ \\\\\\\\\\\\\\\\\\\\\\ Date: \\\/\\\/\\\
Person Obtaining Consent (Printed Name and Signature)

Version: 1.0

Date: [Insert Date]

Approval: This informed consent document was approved by [Insert IRB/IEC Name] on [Insert Date]

{DateTime.UtcNow:HH:mm}

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Analysis

This comparison demonstrates the different approaches each AI model takes when responding to the same prompt. Here are the key differences observed:

Response Characteristics

Claude: Provides a detailed response with 23 sentences.

Grok: Provides a direct response with 125 sentences.

Mistral: Provides a detailed response with 25 sentences.

Key Takeaways

  • Each model brings unique strengths to this type of query
  • Response styles vary significantly between models
  • Consider your specific use case when choosing between these models

Try This Comparison Yourself

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This comparison was generated using the SNEOS AI Comparison ToolPublished: October 15, 2025 | Models: Claude, Grok, Mistral